Senior Regulatory Affairs Specialist
SENIOR REGULATORY AFFAIRS SPECIALIST
Careers that Change Lives
The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to introduce new Class II and Class III Renal Denervation products to market within the US and International Regions. Renal Denervation is an innovative technology focused on revolutionizing the treatment of uncontrolled hypertension. Medtronic Renal Denervation utilizes a minimally invasive radio frequency catheter paired with an RF generator to ablate the renal arteries with the intended purpose of reducing high blood pressure.
The right candidate will provide advice and strategic direction for regulatory filings as well as prepare worldwide regulatory submissions including but not limited to original IDEs and PMAs, IDE and PMA Supplements, FDA Pre-Submissions, Shonin applications, Canadian Medical Device License Applications, and EU MDR Design Dossiers. This role works within a matrixed, collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.
This role is an excellent opportunity for the right regulatory professional to take their pre-market regulatory career to the next level at the world’s leading medical device company. The right individual for this role will thrive in an ever-changing environment that requires creative strategies and the ability to quickly pivot between priorities and will be afforded the opportunity to sit on product development core teams representing the Regulatory function. This role works under minimal day-to-day supervision and will be expected to mentor more junior members of the Regulatory team.
A Day In The Life
- Prepare regulatory strategies/plans and ensure compliance to worldwide requirements. Provide on-going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
- Prepare worldwide submissions for new products and their product changes as required to ensure timely approval for clinical studies and market release. Review significant regulatory issues with management, as necessary, and negotiate submission issues with regulatory agencies.
- Provide business and product information enabling development of strategies and requirements and communicate project status and information to the management teams. Provide review of advertising and promotional/ training materials for new products.
- Develops solutions to a variety of technical problems. Actively participates in problem solving discussions and recommends solutions.
- Frequent use and application of technical or regulatory principles, theories and concepts. Recognizes and communicates problems that may affect the business or regulatory objectives.
- Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance. This includes reviewing labeling, promotional materials, training materials, 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.
- Negotiate directly with the FDA or other regulatory bodies, as needed. All significant issues will be reviewed with management.
- Participate in the development of general strategies, including how to interact more effectively with regulatory agencies and agency personnel, including submissions and audits.
- Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
- Work under general supervision following established procedures. Independently determines and develops strategic approach.
- Frequent inter-organizational and outside customer contacts.
- Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas. Continued focus on driving improvement in processes.
- Provide mentorship, training and support to other members of the department.
- Other tasks, as required.
Must Have: Minimum Requirements
- Bachelor’s Degree in Science, Engineering, Healthcare, or related field
- Minimum of 4 years of medical device regulatory experience, or advanced degree with a minimum of 2 years medical device regulatory experience
Desired / Preferred Qualifications
- Direct experience authoring regulatory submissions in at least one of the following Tier 1 geographies: US, EU, Japan
- Knowledge of FDA, EU, MHLW, Heath Canada, CMDE and TGA requirements
- Experience with PMA and IDE submissions
- Medical Device Labeling requirements and standards
- Technical Writing
- Systems Knowledge such as RA systems, content management systems
- History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.
- Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, IEC 60601, and other global regulatory requirements and quality standards
- Computer skills including Microsoft Office, Adobe Acrobat, and Microsoft Teams
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 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)
