This Sr 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 and Quality for Straumann North America.
This position is responsible for, but not limited to, the following:
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.
B.S. degree, preferably in a scientific or technical discipline or related work experience
Minimum 7 years experience in Regulatory Affairs
Required Knowledge and Skills:
Good working knowledge of FDA and Health Canada regulations
Strong organizational and interpersonal skills
Strong written and oral communications skills
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
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.