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Senior Regulatory Affairs Specialist

2 months ago

California, United States Proclinical Staffing Full time

Regulatory Affairs Manager - Permanent Position

Proclinical is in search of a Regulatory Affairs Manager for a prominent global medical device organization. This is a permanent opportunity.

Key Responsibilities:

In this position, you will offer direct assistance to the company’s operations for their worldwide product offerings. This role encompasses global regulatory responsibilities, collaborating closely with site Quality, Research & Development, Operations, and regional Regulatory Affairs colleagues to facilitate global licensing and registrations, while ensuring the effective management of changes.

Qualifications & Experience:

  • A Bachelor’s degree in a scientific field is essential; an advanced degree is advantageous.
  • Over 10 years of experience within the medical device sector, with at least 5 years in the Electrical/Active medical device domain.
  • A minimum of 5 years of practical knowledge regarding global medical device regulations, requirements, and standards.
  • At least 2 years of experience in managing personnel, both directly and indirectly.
  • Proven experience in independently preparing comprehensive 510k submissions, Health Canada Medical Device license applications (Class II or higher), and EU MDR technical file dossiers (Class II or higher).
  • Participation in national or international standards initiatives is required.
  • Eligibility to work in the United States is mandatory.

The Regulatory Affairs Manager will:

  • Be accountable for formulating and executing global regulatory strategies and roadmaps, leveraging a thorough understanding of the competitive market landscape, regulatory and legislative developments, and product marketing strategies for the product portfolio.
  • Lead regulatory teams to ensure prompt product registrations, regulatory planning for new product launches and modifications, and assist in upholding regulatory compliance.
  • Provide regulatory planning, guidance on risk assessments, and necessary corrective actions to fulfill regulatory obligations, along with leadership on global regulatory strategies, including US FDA product clearance, Health Canada registration, CE Marking, global product registrations, and clinical evaluations.

Proclinical is a specialist employment agency and recruitment business, offering job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.