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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 position.

Key Responsibilities:

In this capacity, you will directly support the company's operations concerning their internationally distributed products. This role encompasses global regulatory responsibilities, collaborating closely with Quality Assurance, Research & Development, Operations, and regional Regulatory Affairs colleagues to facilitate global licensing and registrations, while ensuring 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 relevant 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 preferred.
  • Eligibility to work in the United States is required.

The Regulatory Affairs Manager will:

  • Be accountable for formulating and executing global regulatory strategies and roadmaps, leveraging a profound understanding of the competitive landscape, regulatory and legislative developments, and product marketing strategies for the product portfolio.
  • Lead regulatory resources to ensure timely product registrations, regulatory planning for new product launches and modifications, while assisting in the maintenance of regulatory compliance.
  • Provide regulatory planning, guidance on risk assessments, and necessary corrective actions to meet regulatory obligations, along with leadership on global regulatory strategies, including US FDA product clearances, Health Canada registrations, CE Marking, global product registrations, and clinical evaluations.

Proclinical is a specialized employment agency and recruitment firm, offering job opportunities within leading pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.