As a regulatory professional, confidence comes from having the answers you need. But what do you do when the answers just aren't there? 2014 RAPS will give you the know-how to tackle your toughest issues.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
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
Straumann is a leading provider of solutions in implant dentistry and dental tissue regeneration. Our mission is to enable dental professionals to restore their patients’ oral function and esthetics through effective, reliable, and safe treatment methods.
In 2005, we opened our new state-of-the-art national headquarters. It embodies the spirit of Straumann with its 160,000 square feet of open,... clean lined modern space. By combining manufacturing, training and education, marketing, and customer service under one roof, we are now able to offer the highest quality of products and services available in the marketplace to our customers.
Straumann USA, LLC, located in Andover, MA, is the US subsidiary of Straumann Holding, headquartered in Basel, Switzerland. As the largest dental implant company in the world, the Straumann Group of companies has an active presence in more than 50 countries.