Overview

Position Summary:

Senior Regulatory Affairs Specialist will be responsible for the creation, preparation and coordination of regulatory submissions and approvals to introduce new products in the domestic and international markets. This includes interpretation of relevant government regulations. Also responsible to provide quality and timely regulatory support to obtain marketing clearance/approval for new products; devices/drugs, drug-device combinations and maintain marketability of existing products.

Key Activities:

  • Assist in the implementation of company’s international regulatory submission strategy.
  • Compile required documents from source areas for submission.
  • Review critical documents to assure completeness, and with supervision, will prepare responses to routine in-country representative or regulatory agency results.
  • Ensure the content, organization and overall quality of all regulatory documentation are adequate and sufficient to comply with local, regional and / or international regulatory requirements, commitments and agreements.
  • Development of tracking documents and follow-up to assure submissions are managed appropriately.
  • Perform the coordination and preparation of document package for regulatory submissions (US and international).
  • Compile all materials required in submissions, license renewal and annual registrations.
  • Keep abreast of regulatory procedures and changes. May have direct interaction with regulatory agencies on defined matters.
  • Represent regulatory affairs on project teams.
  • Develop and recommend strategies for earliest possible approvals of device applications.
  • Generate departmental procedures.
  • Ensure documents are apostilled, certified and legalized or notarized, as required.
  • Assess new and / or modified standards, regulations and / or laws and determine applicability to the organization and / or product.
  • Complete other related duties as required.
  • Conduct oneself consistent with company standards at all times during work hours or when acting as a representative of the company.

Required Qualifications:

  • Bachelor’s degree required in a technical discipline, such as Engineering, Bio-Medical Engineering, Computer Science, Biology or Chemistry. Masters Degreed preferred.
  • Minimum 8 – 10 years’ experience in Regulatory Affairs in the medical device/drug industry.
  • Must have experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America.
  • Must have experience with Standards (ISO, IEC and EN).