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Senior Regulatory Affairs Specialist

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Senior Regulatory Affairs Specialist


Boulder, Colorado, United States

Requisition #:


Post Date:

Mar 16, 2022


Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world. These opportunities stretch across all Medtronic Business Units, Product Groups and Geographies. Those working within Regulatory Affairs have direct impact on Medtronics ability to provide leading-edge medical solutions to people around the globe.

**Careers That Change Lives**

The **Senior Regulatory Affairs Specialist (Sr. RAS)** is responsible for planning and executing regulatory activities necessary to obtain and maintain regulatory approvals within the EU and International Regions. The Sr. RAS will provide support for regulatory activities including: technical writing to support regulatory submissions and product labeling and instructions for use creation. The Sr. RAS translates regulatory requirements into project/product requirements and collaborates cross-functionally while ensuring timely and high-quality execution of assigned regulatory deliverables.

**A Day in the Life**

+ Author EU MDR Technical Documentation.

+ Assist in keeping the company informed of regulatory requirements in the EU.

+ Participate in cross-functional teams, providing regulatory input in alignment with the EU MDR strategy

+ Review Change Orders and assess regulatory labeling impact of product changes on US, EU and/or International regulatory strategy and submissions per standard procedures

+ Excellent communication skills, strong documentation skills, strong attention to details and technical writing including authoring regulatory documentation, SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.

+ Review labeling materials

+ Follow all work/quality procedures to ensure quality system compliance and high-quality work.

+ Comply with applicable regulatory laws/standards and the Medtronic Code of Conduct

+ Other duties as assigned or required

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 4 years of relevant experience in the medical device, biotech, or pharmaceutical industry

+ Or an advanced degree with a minimum of 2 years relevant experience in the medical device, biotech, or pharmaceutical industry

**Nice to Have**

+ US and International medical device regulatory submission/approval experience, to include FDA and EU

+ Knowledge of FDA, EU MDD, and EU MDR requirements

+ Experience of working with Class III US and/or EU medical devices

+ Medical Device Software experience

+ Product Labeling requirements and standards

+ Design Dossier and/or Technical Documentation experience

+ Technical Writing

+ May have practical knowledge of project management

+ Systems Knowledge such as RA systems, Agile, SharePoint, Box or Quality Management Systems

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

**Physical Job Requirements**

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. (ADA-United States of America)
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.


Posted: 2022-03-18 Expires: 2022-05-27
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