Regulatory Affairs Specialist

1 week ago

Minneapolis, Minnesota, United States Actalent Full time
Job Title: Regulatory Affairs Specialist

Actalent is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.

Key Responsibilities:
  • Communicate with regulatory agencies to ensure compliance with pre-submission strategies, regulatory pathways, and compliance test requirements.
  • Provide technical review of data and reports to be incorporated into regulatory submissions.
  • Analyze validation test data to determine whether systems or processes meet validation criteria.
  • Study product characteristics and customer requirements to determine validation objectives and standards.
  • Identify deviations from established product or process standards and provide recommendations for resolving deviations.
  • Develop validation master plans, process flow diagrams, test cases, and standard operating procedures.
  • Prepare, maintain, and review validation and compliance documentation.
  • Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
  • Prepare additional information or responses as requested by regulatory agencies.
  • Research and interpret regulatory rules or rule changes and ensure they are communicated through company procedures.
Requirements:
  • 8-10 years of regulatory affairs experience.
  • +5 years of FDA and EU experience.
  • MDD to MDR transition experience.
  • 510k submissions experience.
  • PMA submission experience preferred.
About Actalent:

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.

We are committed to diversity, equity, and inclusion and strive to create a culture of care, engagement, and recognition with clear outcomes. We are an equal opportunity employer and welcome applications from diverse candidates.

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