Sr. Regulatory Affairs Specialist - Pelvic Health

Medtronic•Minneapolis, MN

4d•Onsite

About The Position

At Medtronic, you can embark on a career of exploration and innovation, contributing to healthcare access and equity. This Senior Regulatory Affairs Specialist position focuses on pre-market and post-market changes within the Pelvic Health Operating Unit. The Pelvic Health unit is dedicated to advancing care for patients with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies. Medtronic emphasizes putting patients first, fostering collaboration, and engineering extraordinary solutions. The company operates onsite four days a week at its Minnesota Rice Creek East facility. Medtronic is seeking a passionate Senior Regulatory Affairs Specialist with direct experience in submitting regulatory submissions for both the Americas and the EU, to contribute to their mission of alleviating pain, restoring health, and extending life.

Requirements

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

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).

Responsibilities

Develop strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to market.
Provide expert advice on regulatory requirements.
Prepare submissions and negotiate their approval.
Assist with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations.
Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.
Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release.
Partner with geography partners to develop regulatory strategy, submit submissions, or respond to regulators.
Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed.
Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls.
Provide 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.
Provide regulatory strategies and support for clinical investigations in the US and worldwide.
Provide feedback and ongoing support to product development teams for regulatory issues and questions.
Interact directly with FDA and international regulatory agencies on most projects/products at reviewer level, with significant issues reviewed with the manager.