Regulatory Affairs Director jobs in Saint Cloud, MN

Careers that Change Lives


A Day in the Life

The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to the market, provides advice on regulatory requirements, prepares submissions, and negotiates their approval. The RA Specialist also assists with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations.

Responsibilities may include the following and other duties may be assigned.

• Prepare FDA, European, and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with the supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
• Prepare regulatory strategies/plans and compliance requirements. Provide ongoing support to project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations.
• Provide business and product information to enable the development of strategies and requirements and communicate that information to the Project teams.
• Provide regulatory support for currently marketed products. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
• Complete understanding and wide application of technical or regulatory principles, theories, and concepts. General knowledge of other related disciplines.
• Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
• Provide regulatory product portfolio analysis and review with other functional resources, such as Marketing, Global Supply Chain, etc. Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Work under general supervision following established procedures. Independently determines and develops an approach.
• Frequent inter-organizational contact and some external contacts.
• Keeps current on global directives, harmonized standards and procedures, and communicates changes that may affect cross-functional areas.
• Other tasks, as required

Must Have: Minimum Requirements

• Bachelor's degree required
• Minimum of 2 years of regulated industry experience.

Nice to Have

• Experience working in a regulated biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and working with cross-functional project teams.
• 4 years of medical device industry experience
• In-depth experience with FDA requirements, guidance documents, Active Implantable Medical Device Directive/ EU Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Experience with Class III medical devices (PMA) and/or active implantable devices
• Strong negotiation skills and written/oral communication skills
• Strong organizational skills and time management skills
• Computer skills: MS Office, MS Project, Adobe Acrobat, and Agile

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. Let’s 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 an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform 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.