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Sr. Mgr International Regulatory AffairsApply Now

Location: Bedford, Massachusetts 01730
Employment Type: Contract

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Job Description

Contract Length:  6 months

Job Summary:  This role supports the regulatory registration of products worldwide and contributes to global expansion business plans by assessing regulatory requirements in various international markets for the company’s products.

Responsibilities:
 
  • Establishes strategy and manages international registration activities for  targeted international markets
  • Collaborates with Business Leads to achieve rapid worldwide registrations
  • Supports continued registration of marketed products on a worldwide basis
  • Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders
  • Participates in interactions/negotiations with international regulatory agencies when needed

Requirements:
 
  • 7-10+ years Regulatory Affairs experience in medical device companies; preferred experience drug/device combination products and orthopedic devices
  • B.A./B.S. degree or higher in a technical discipline, preferable in engineering, bioengineering, biology, or chemistry desired or equivalent experience.
  • Experience with international submissions for medical device and drug regulatory required
  • Experience supporting product development and/or product support projects

Contact

Christian Griffith
Principal Recruiter


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