Sr. Regulatory Affairs Specialist - Pelvic Health at Medtronic Plc

Senior Regulatory Affairs Specialist

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. This position will work on pre-market and post-market changes for the Pelvic Health Operating Unit. In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who has direct experience submitting regulatory submissions for both the Americas and the EU.

Role Overview: The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to market. This role involves:

• Providing expert advice on regulatory requirements
• Preparing submissions
• Negotiating their approval
• Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations.
• Teaming with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.
• Collaborating with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Preparing FDA, European, and Canadian submissions for product changes to ensure timely approval for market release.
• Partnering with geography partners to develop regulatory strategy, submit submissions, or respond to regulators.
• Reviewing significant regulatory issues with the manager as necessary, and resolving submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed.
• Supporting regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls.
• Providing regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation.
• Support of marketing claim development and review of advertising and promotion materials.
• Regulatory strategies and support may also include clinical investigations in the US and worldwide.
• Providing feedback and ongoing support to product development teams for regulatory issues and questions.
• Interacting directly with FDA and international regulatory agencies on most projects/products at reviewer level, with significant issues reviewed with the manager.

To Be Successful in This Role:

• Medical Device Experience: Direct experience in the medical device industry, particularly with Class III medical devices (PMA).
• Regulatory Submission Expertise: Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies.
• Knowledge of Regulatory Requirements: In-depth understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.
• Strong Communication Skills: Excellent negotiation, written, and oral communication skills to effectively interact with regulatory agencies and cross-functional teams.
• Organizational Skills: Strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.
• Independence and Initiative: Ability to work independently and under general direction only.
• Computer Skills: Proficiency in MS Office, MS Project, Adobe Acrobat, and Agile.

Must Have: Minimum Requirements Bachelor's degree in a scientific discipline or equivalent with 4 years of relevant experience, or an advanced degree with 2 years of experience.

Nice To Have: 5-8 years of industry experience, with at least 2-3 years in regulatory, engineering, clinical, or quality roles. Advanced degree and experience in a scientific discipline (engineering, physical/biological, or health sciences). Experience working in a regulated biotechnology environment, including extensive involvement with regulatory submissions and interactions with regulatory agencies. History of successful device submissions. Engineering or Cybersecurity / Software / AI experience (strong plus).

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.

Join us in our mission to alleviate pain, restore health, and extend lifewhere your unique background and perspective are valued. 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.