At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Basic Energy and Access and Instrument product portfolio modifications. Activities include submissions ( e.g., 510(k), CE technical file), regulatory compliance assessments, compile international submissions and supporting EU MDR implementation. The Sr. RAS MDR role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices. The initial project scope for this employee will be related to regulatory sustaining activities. NPD activities may be tied into the role later on.
Location: Strong preference to have candidates work hybrid from Boulder, CO. Remote within the U.S. may be considered for the right candidate.
Responsibilities may include the following and other duties may be assigned.
Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations
Prepare 510(k) submissions and technical documents to support CE mark and other international submissions
Participate in negotiations and interactions with regulatory authorities during the development and review process
Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team
Support international product registrations as needed
Manage multiple projects and prioritize tasks on day by day basis to meet project schedules
Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
Review promotional and advertising material
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
Participate in internal and external audits as needed
Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Perform other duties as assigned or required
Required Knowledge and Experience:
Bachelors degree with 4+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry
OR
An advanced degree with 2+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry
Nice to Have
Knowledge of FDA and EU MDR requirements
Experience of working with all classification of product in the U.S and/or EU.
International medical device regulatory submission/approval experience, to include FDA and EU (specifically EU MDR)
Product Labeling requirements and standards
May have practical knowledge of project management
Systems Knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$88,800.00 – $133,200.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
At Medtronic, most positions are posted on our career site for 3-7 days.
Administer, develop and manage interface resources to ensure quality, availability, stability, security and recoverability. Develop enterprise interfaces utilizing file-transfer, network transfer and HL7 technologies in order to link disparate systems throughout the enterprise. Coordinate development with vendors, project managers, end users and other IS staff in order to achieve the highest level of integration possible. Maintain and follow documented programming standards, disaster recovery procedures and performance monitoring guidelines. Create/maintain overall interface environment documentation. Needs to follow the DCH ITIL change management processes in order to ensure proper testing and data validations. This position is expected to have full knowledge of the DCH ITIL processes and follow established IS policies and procedures.
Education
REQUIRED: Bachelor’s Degree in MIS, Computer Science, or related field
Certification
PREFERRED: EPIC Bridges Certification, Corepoint Certification, or other Interface Engine Certification
Experience
REQUIRED: 2-3 experience specializing in interface development or computer programming, basic knowledge of Microsoft Office and email products, strong problem solving, excellent verbal and written communication skills
PREFERRED: 2-5 years healthcare experience, 4-7 years Interface development or computer programming experience
An exciting opportunity exists for an Inpatient Remote Medical Coder with Medical Reimbursement (a division of Coronis Health). The Inpatient Medical Coder plays a critical role in the healthcare revenue cycle by reviewing, analyzing, and accurately coding diagnostic and procedural information to determine Medicare, Medicaid, and private insurance payments. The ideal Inpatient Coders will have prior training both in-class and on-the-job, and a broad understanding of medical terms related to anatomy, biology, and pharmacology.
Duties and Responsibilities:
Code Medical Records: Assign and sequence ICD-10-CM, CPT, HCPS, DRG and PCS assignment codes to diagnosis and procedures based on documented information.
Validity Assurance: Ensure the final diagnoses and operative procedures, as stated by the physician, are valid and complete.
Information Abstraction: Abstract all necessary information and assign codes that most accurately describe each documented diagnosis, surgical procedure, and special therapy or procedure following established guidelines.
Auditing documentation: Perform a comprehensive review of medical records, verifying patient and record identification, required signatures and dates, as well as other necessary data to validate documentation supports services rendered.
Consistency Evaluation: Evaluate the record for documentation consistency and adequacy.
E&M Level Analysis: Analyze provider documentation to ensure appropriate Evaluation & Management (E&M) levels are assigned using the correct CPT code as needed.
Identity discrepancies: analyze, recommend, and facilitating plan of action to correct discrepancies and prevent future coding errors.
Ability to write queries that are appropriate to case and are non-leading.
Experience using 3M and EPIC
Qualifications:
Education: High School diploma or equivalent.
Experience: Two years of coding experience.
Certification: AAPC: CPC, CIC, or COC
AHIMA: CCS or CCS-P certification required.
Physical Requirements:
The following physical requirements are representative of the capabilities necessary to perform essential job functions:
Ability to sit, talk, and hear for extended periods.
Regular to seldom basis standing, walking, pushing/pulling, bending, stooping, kneeling, and reaching.
Frequent repetitive hand motions including fingering, grasping, and handling.
Ability to read handwritten and typed documents on paper and/or computer screens.
Note: Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Benefits:
Competitive salary based on experience and qualifications.
Comprehensive health, dental, and vision insurance plans.
Retirement savings plan with employer contribution.
Paid time off and holidays.
Professional development opportunities.
Employee assistance program.
The Coronis Family of Companies is an equal opportunity employer, committed to diversity and fostering an inclusive environment for all employees
At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do.
Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.
Owens & Minor teammate benefits include:
Medical, dental, and vision insurance, available on first working day
401(k), eligibility after 30 days of employment
Employee stock purchase plan
Tuition reimbursement
Development opportunities to grow your career with a global company
As a technical writer for Apria Healthcare, you will be responsible for creating, proofing, editing, formatting, and maintaining business resources.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Serves as an information architect, determining the optimal way to organize, craft, and deliver information to the business, ensuring maximum readability and usability of final products.
Applies rigorous attention to detail to deliver reference materials and communications that are grammatically correct, technically correct, properly formatted, error-free, and user-friendly.
Follows industry-standard development models and makes use of a variety of creative and innovative approaches to create or support the creation of effective resources.
Crafts and refines deliverables for a variety of scenarios and use cases across the enterprise.
Owns or facilitates the development of resources, using various media types and delivery methods, including how-to guides, policies and procedures, corporate communications, executive presentations, associated graphics and visual aids, process flows, forms/letters, and more.
Researches, analyzes, and evaluates materials to ensure they are coherent and consistent, collaborating with process specialists to identify and remediate process or logic gaps.
Works with subject matter experts (SMEs) to identify specific resource needs and develop solutions.
Explains detailed information and ideas in simple language, ensuring deliverables are clear and concise.
Serves as SME and mentor for process specialists throughout the drafting, editing, and publishing cycle, conducting online tutorials and crafting internal support materials to provide clarity, as applicable.
Supports complex initiatives and works multiple initiatives simultaneously, adhering to all project timelines.
Adheres to brand standards, applicable style guides, and internal style guidelines.
Performs other duties as required.
If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.
Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
The ABL Underwriter analyzes, assesses, and documents the critical components of a credit decision. This role conducts industry and company research, prepares accurate and timely credit approval documentation, and participates in credit approval presentations. The ABL Underwriter pro-actively evaluates credit decisions and opportunities to mitigate associated business risks relying on established Huntington policies, procedures, and legal and regulatory requirements. This individual will also own primary responsibility for underwriting quality.
Duties & Responsibilities
Utilizes Huntington National Bank’s financial spreading software to analyze year end and interim financial statements.
Uses the Bank’s risk rating model and prepares the credit approval document for new prospects.
Assesses the primary risks of the credit extension and the nature of the mitigating factors.
Accurately and appropriately analyzes financial statements, calculates cash flow coverage, leverage, and other relevant financial ratios; discusses deal-specific cash flow modifications and determines for reasonableness.
Presents underwriting document incorporating financial, business, industry and risk analysis in a concise effective manner.
Assists Portfolio Management as necessary.
Basic Qualifications
Bachelor’s degree in Finance, Accounting, or Business
Minimum 2-3 years’ experience in ABL Underwriting or Portfolio Management.
Preferred Qualifications
Proficiency with Microsoft Office Products (Word, Excel, etc.).
Sharp analytical and decision-making skills.
Strong organizational, verbal and written communication skills.
Field Exam experience preferred.
#LI-Remote
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Exempt Status: (Yes = not eligible for overtime pay) (No = eligible for overtime pay)Yes
Workplace Type:Remote
Huntington is an equal opportunity and affirmative action employer and is committed to providing equal employment opportunities for all regardless of race, color, religion, sex, national origin, age, disability, sexual orientation, veteran status, gender identity and expression, genetic information, or any other basis protected by local, state, or federal law.
The Program Monitor provides advice, consultation, and technical assistance to care providers supporting the implementation and coordination of a government program providing services to individuals. The Program Monitor develops and administers plans to ensure government funded programs serving individuals comply with established regulations, policies, and procedures.
Essential Tasks Include:
Conducts on-site monitoring on the programmatic and technical aspects of assigned applications, contracts, and grants.
Assesses quality of services and safety of individuals at the care provider.
Identifies care providers’ technical assistance needs and determines potential compliance/logistical issues.
Reviews equipment and property inventory.
Conducts entrance and exit meetings with the care providers to discuss the monitoring process, including program challenges and the mechanism for feedback.
Conducts interviews with care provider staff, individuals under the providers care, and external stakeholders to obtain information about program administration, operations, and quality of services rendered.
Reviews program documentation and program files including case files and personnel files to ensure compliance.
Compile and submit monitoring report within fifteen business days of monitoring visit.
Preserves a historical record of all notes/documents/records of monitoring trips.
Maintains current knowledge of agency specific policies, procedures, and standards for programs.
Provides technical assistance, and guidance on child welfare best practices and policies and procedures to care provider staff and programs for areas of improvement observed during monitoring visits.
Qualifications:
Requires BS/BA degree in social work or related field plus 5 years of related work experience.
Proven experience monitoring grantees that provide services to underserved populations.
Previous quality assurance, case management, and/or clinical experience is preferred.
Ability to conduct frequent travel, completing trips to designated sites up to 50% of the time.
Excellent communications skills, both written and verbal.
Bilingual – English/Spanish speaking is highly preferred.
High attention to detail.
Ability to obtain a Public Trust clearance.
Texas and Florida candidates preferred.
The likely salary range for this position is $87,030 – $117,746. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Scheduled Weekly Hours: 40
Travel Required: 10-25%
Telecommuting Options: Remote
Work Location: Any Location / Remote
Additional Work Locations:
Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. GDIT typically provides new employees with 15 days of paid leave per calendar year to be used for vacations, personal business, and illness and an additional 10 paid holidays per year. Paid leave and paid holidays are prorated based on the employee’s date of hire. The GDIT Paid Family Leave program provides a total of up to 160 hours of paid leave in a rolling 12 month period for eligible employees. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
We connect people with the most impactful client missions, creating an unparalleled work experience that allows them to see their impact every day. We create opportunities for our people to lead and learn simultaneously. From securing our nation’s most sensitive systems, to enabling digital transformation and cloud adoption, our people are the ones who make change real.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.
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