Regulatory Affairs Specialist
10. Jan 2019
Andover - USA
Fachleute (erfahren, Spezialisten)
Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape the future and create impact. Encouraging leadership and inspiring ideas from our people have guided us through our proud history of pioneering innovations.
- Position Summary
- Generate and review regulatory submissions (510(k), PMA, IDE, License Applications, etc.) to obtain FDA and Health Canada clearance/approval to commercially distribute products.
- Produce subsequent regulatory submissions (annual reports, change notifications, memos to file, etc.) to facilitate the maintenance of the FDA and Health Canada clearances/approvals.
- Provide input to development teams to assure that North American regulatory requirements and standards are incorporated in the product development process.
- Review promotional material and labeling to ensure applicable regulatory requirements are met.
- Keep abreast of new or changes in FDA or Health Canada regulations or Guidance Documents.
- Support regulatory compliance of the US and Canadian Sales Organizations (e.g., distribution and complaint handling).
- Maintains establishment registrations and device listings with FDA.
- Regulatory release of new products for North America.
- Support Freedom of Information Act requests from the FDA.
- Support logistics in providing regulatory information for incoming product shipments.
- Support worldwide registration, including overseeing notarization and legalization of documents and overseeing the request for Certificates to Foreign Government, etc.
- Prepares and updates regulatory policies and procedures.
- Other duties as assigned.
The Regulatory Affairs Specialist is responsible for researching scientific and regulatory information for review and preparation of regulatory submissions intended for the FDA and Health Canada. This position will work with the FDA and Health Canada to ensure approval of products. In addition, this person is responsible for review of promotional material and labeling for compliance with FDA and Health Canada regulations and overseeing annual establishment registrations and device listings. This position works under minimal supervision and reports to the Director, Regulatory Affairs for Straumann North America.
This position is responsible for, but not limited to, the following:
- B.S. degree, preferably in a scientific or technical discipline or related work experience
- Minimum 1-2 years’ experience in Regulatory Affairs or working in a regulated industry
- Good working knowledge of FDA and Health Canada regulations
- Strong organizational and interpersonal skills
- Strong written and oral communications skills
- Detail oriented
- Proficiency with PC computer and Microsoft Office software
- Technical knowledge of medical devices
- Able to manage multiple projects with shifting priorities
- Able to work independently with limited supervision
- Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills, with limited supervision
Required Knowledge and Skills: