Medtronic is an Equal Opportunity/Affirmative Action Employer
The Regulatory Affairs Specialist will represent Regulatory Affairs on new product and therapy development teams, product continuation teams, and other business initiatives. The Regulatory Affairs Specialist will provide strategic guidance regarding domestic regulatory requirements and have responsibility for obtaining and maintaining worldwide product and therapy approvals.
Assists with preparation of US regulatory submissions including IDE, PMA, and 510(k) submissions, amendments, and supplements
Negotiates with regulatory agency, staff, and lead cross-functional team efforts to resolve potential regulatory issues and questions from regulatory agencies
Collaborates with RA partners to support filings
Provides regulatory affairs tactical support for all aspects of product development and manufacturing, clinical studies including pre-market, post-market and physician-initiated studies
Supports regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed
Maintains proficiency in regulatory requirements; establish and maintain good relationships with agency personnel
Establishes and builds upon broad personal network across functions, throughout Medtronic, with regulators and external industry bodies
Demonstrates proficiency in regulatory knowledge in pre- and post-market submissions, products, and geography regulations
Plays and active role in effectively planning and driving successful completion of complex cross-functional projects
Maintains strong understanding of product lines/disease states, customers, product distribution release processes and geography launch/maintenance requirements
Works with Regulatory Affairs staff, engineers, and technical experts to resolve questions and issues
Effectively communicates project plans, status and resource requirements to both core teams and senior management
Partners with other Regulatory Affairs Specialists and others in the organization
Other duties as assigned
Education & Experience Required:
Bachelor’s degree in Engineering, Regulatory Science, Business, Life Sciences, or related technical field and 3 years’ of related experience in regulatory
Master’s Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related technical field and
1 years of related experience in regulatory
Organized, efficient, process-oriented
Effective interpersonal/communication skills; demonstrated advanced writing/technical writing skills
Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills
Self-motivated and proactive team member
Strong work ethic
Works well under pressure in a dynamic timeline-driven environment
Education & Experience Preferred:
More than 4 years’ of related experience Bachelor’s degree in Engineering, Regulatory Science, Business, Life Sciences, or related technical field
More than 2 years’ of related experience with Master’s degree or Doctorate in Regulatory Affairs, Engineering, Quality or related Technical field
Other preferred qualifications:
Experience in medical device
Working knowledge of medical device regulations, including submissions
Have detailed knowledge of domestic and international medical device regulatory requirements.
Ability to effectively manage multiple projects and priorities.
Results-oriented and decisive.
Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards.
Flexible with priorities and responsibilities.
Regulatory Affairs Certification (RAC) preferred.
Physical Job Requirements
Able to sit/stand for 8 hours per day
Able to travel domestic/international up to 20% of the time
Medtronic - 2 years ago
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...