Senior Principal Regulatory Affairs Specialist
St Louis Park, MN
Full Time
Experienced
St. Louis Park, MN - Hybrid
Company Summary:
Enterra Medical is a medical device company dedicated to a singular focus: helping more people with chronic gastroparesis live better lives by advancing technology, expanding clinical science, and accelerating access to the Enterra® Therapy.
Position Summary:
The Senior Principal Regulatory Affairs Specialist will be responsible for regulatory strategies and associated daily activities. The ideal candidate will have need to have a minimum of 10 years' experience in Medical Device Regulatory Affairs.
Duties and Responsibilities:
Company Summary:
Enterra Medical is a medical device company dedicated to a singular focus: helping more people with chronic gastroparesis live better lives by advancing technology, expanding clinical science, and accelerating access to the Enterra® Therapy.
Position Summary:
The Senior Principal Regulatory Affairs Specialist will be responsible for regulatory strategies and associated daily activities. The ideal candidate will have need to have a minimum of 10 years' experience in Medical Device Regulatory Affairs.
Duties and Responsibilities:
- Responsible for the strategic direction, planning and management of Regulatory projects and activities for Enterra Medical products
- Achieve regulatory deliverables within project timelines and milestones with relevant FDA, EU, ISO and other regulatory requirements and standards
- Responsible for pre-market activities and post-market regulatory affairs activities
- Support clinical evaluation approvals for various therapy needs domestically and internationally
- Author and submit regulatory filings
- Manages and maintain worldwide country registrations and regulatory databases for the FDA and Notified Bodies and other regulatory agencies
- Ensure documents meet regulatory requirements for FDA, Notified Bodies, and other agencies
- Report analysis of regulatory strategy and status to the company
- Review and assesses marketing materials for compliance
- Drive continuous improvement in Regulatory processes
- Represent regulatory affairs in product development project teams
- Define the requirements for regulatory submissions for international and domestic markets
- Work with Operations team to assure regulatory compliance.
- Other duties as assigned.
- 10+ years of experience in Medical Device Regulatory Affairs required.
- Organizational management, technical management, skilled at organizational procedure and policy making, successes leading teams, excellent understanding of technology and regulations.
- A track record of implementation and management of quality management systems
- Ability to communicate effectively, orally and in writing
- Direct experience interacting with FDA on PMAs and PMA Supplements, European Notified Bodies on CE Marks, and other regulatory bodies in other regions of the world
- Ability to travel to meet with customers, suppliers, and other stakeholders
- A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices and/or in vitro diagnostic medical devices.
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