The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
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/clearance/license 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/license 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/licenses.
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 5-7 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
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
Internal Number: 546262
About Straumann Group
Straumann® stands for premium Swiss quality, precision and innovation delivering confidence in dentistry, backed by the largest global scientific network. As the global leader in implantology, we deliver cutting-edge innovations that are regarded as industry benchmarks and disruptive technological breakthroughs, supported by long-term scientific evidence. We push the boundaries to enable the next generation of dental care.