Les offres d'emploi : Professions sociales - Santé ...

This is a position for an experienced Regulatory Affairs (RA) professional. The entrant should have from at least 2 to 5 years of RA experience. The candidate's regulatory background should include the medical device area, and preferably should include orthopaedic experience. Experience in the areas of drug, biologics, and combination products regulations is also desirable.The occupant will have expertise in areas that include preparation of dossiers for product registrations outside the U.S.; preparation of submissions to the U.S. FDA; U.S. FDA regulations, including labeling regulations; regulations of countries outside the U.S.The occupant may perform some or all of the following functions, depending upon their specific assigned focus, working with minimum supervision.
- Coordinates and manages FDA regulatory submission process, including authoring and publishing electronic submissions.
- Coordinates and manages the development of dossiers for registration of products in countries outside the U.S, including authoring and publishing electronic submissions.
- Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
- Reviews proposed labeling for compliance with applicable U.S. and international regulations.
- Writes/manages the development of package inserts.
- Reviews and evaluates promotion and advertising material for compliance with applicable regulations.
- Reviews proposed product changes for impact on regulatory status of the product.
- Demonstrated strong writing and communication skills.
- Strong attention to details, and ability to multitask.
- Understands the overall business environment, the orthopaedic industry and the marketplace.
- Functional knowledge of relevant regulations, and ability stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products.
- Ability to function well as a member of the team and build relationships between RA and other areas of the organization.
- Able to identify and assess business risks for a given Regulatory strategy.
- U.S Bachelor's Degree (4 year university degree) or ex-U.S. equivalent. Degree or background in life sciences, technical (engineering) or related field.
- English fluency, German is an asset.
- Regulatory Affairs Certification (U.S. or EU) preferred.
- Travel Requirements- 10-15%


MICHAEL PAGE CONTATC :
Your application will be sent to Stefano Chiei Gamacchio (Zurich Office); please quote the job reference kSCH15257

Our client is a leading global player within the orthopaedic biomedical technology field. Due to straordinary growth of there will be the need to reinforce the esistent organization.