Prin Regulatory Affairs Spec - Core Surgical innovations

Medtronic•Mounds View, MN

5d•$120,000 - $180,000

About The Position

The Principal Regulatory Affairs Specialist develops and executes strategies for global regulatory approvals to introduce new and modified medical device products to the market. The Principal Regulatory Affairs Specialist translates regulatory requirements into project/product requirements, prepares worldwide regulatory submissions and negotiates their approval. Responsibilities include participating on product development teams, developing global regulatory strategies, preparing US and international regulatory submissions, supporting pre and post market regulatory compliance activities and evaluating proposed product changes for regulatory impact and preparing necessary documentation.

Requirements

Bachelors degree with 7+ years of regulatory affairs experience OR An advanced degree with 5+ years of regulatory affairs experience
U.S. work authorization at the time of hire and for the duration of employment (unless hired into a Principal-level role or above where sponsorship may be offered).

Nice To Haves

7+ years of medical device regulatory affairs with roles showing increasing responsibility
Experience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Strong leadership and team management skills.
Excellent communication and interpersonal skills.
Ability to thrive in a fast-paced, collaborative environment.
Strong problem-solving and decision-making abilities.
Experience with Notified Body audits.
Collaboration and leadership skills in team setting including ability to coach and develop team members, and effective resource management to address multiple priorities.
RAC credential preferred
Strong interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey”
Ability to analyze and resolve non-routine regulatory issues using independent judgment
Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
Demonstrated history of successful regulatory submissions in the US and EU
Experience with software-enabled medical devices, including artificial intelligence and machine learning technologies, as well as clinical trials and preclinical testing.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

Develop and implement comprehensive global regulatory strategies for medical device submissions to ensure timely market access for New Product Development
Author regulatory submissions, including but not limited to pre-submissions, premarket notifications (510(k)s), EU change notifications, and technical documentation.
Serve as a key regulatory representative on cross-functional product development teams, providing strategic input, timelines, and direction.
Review and approve product labeling, training materials, promotional content, and advertising for regulatory compliance.
Support global pre-market and post-market regulatory activities to maintain product approval and lifecycle compliance.
Oversee and coordinate multiple regulatory projects across domestic and international markets.
Provide strategic leadership and mentorship to Regulatory Affairs Specialists in the development of regulatory submissions and interpretation of global regulations.
Lead or coordinate the preparation of regulatory submission documentation, as well as internal audit and inspection readiness activities.
Recommend and implement changes to labeling, manufacturing processes, marketing strategies, and clinical protocols to ensure regulatory compliance.
Monitor and enhance regulatory tracking and control systems to drive process efficiency and documentation integrity.
Maintain up-to-date knowledge of evolving global regulatory requirements, guidance, and industry best practices.
Interface with regulatory authorities as required on defined matters, ensuring effective communication and resolution of issues.
Actively participate in internal and external audits, providing subject matter expertise as needed.
Review of promotional and advertising material.