Vacancy caducado!
We are seeking a Sr. Regulatory Affairs Specialist for a direct-hire role with a leading client in St. Paul, MN. In this role, you would have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. This opportunity is with a market-leading family-owned, global technology company that impacts a wide variety of industries to include the healthcare/medical, automotive and food industries.
Role and Responsibilities:- Provide regulatory affairs support for component, contract and finish device manufacturing
- Develop and execute on Regulatory Affairs Plans to support product realization activities
- Supervise complaint handling process and other post market surveillance activities relate to finished devices
- Support global sites in maintaining ISO certifications and track correspondence from Notified Bodies
- Submit request for Certificates from the FDA for International Regulatory Compliance and Export Requirements
- Create and defend regulatory submissions and approvals (CE mark technical documentation, US FDA filings, other country registrations)
- Responsible for leading one colleague, who will be supporting you on your activities
- Undergraduate degree science, engineering or technical writing with 3-5 years in a medical device regulatory affairs or quality department. 0-3 years in a regulatory affairs role with US FDA and EU responsibility
- Experience with cardiovascular and/or neurology medical devices preferred
- US FDA Regulatory Affairs and US FDA Medical Device Listing and Establishment Registrations experience
- EU Medical Device Regulation experience preferred. Understanding of International Regulatory Affairs requirements
- Post Market Surveillance Reporting
- Leadership skills