Manager of Regulatory Compliance

1 week 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 offer direct assistance to company operations for their internationally distributed products. This role involves 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 mandatory; an advanced degree is highly desirable.
  • 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 people management, both direct and indirect.
  • 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).
  • Experience in engaging with national or international standards initiatives.
  • 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 market landscape, regulatory and legislative developments, and product marketing strategies for the product portfolio.
  • Lead regulatory teams to ensure timely product registrations, regulatory planning for new product launches and modifications, and assist in upholding regulatory compliance.
  • Provide regulatory plans, guidance on risk assessments, and necessary corrective actions to fulfill regulatory obligations, alongside leadership and direction 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.



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