Regulatory Affairs Specialist

About the Role

Provide regulatory guidance throughout product development and manufacturing to ensure compliance with domestic and international standards. Collaborate with external authorities and internal teams to facilitate product approvals and submissions, including preparing documentation, tracking milestones, and supporting audits. Monitor global regulations, assess their impact, and suggest strategies to expedite approval processes. Review labeling, product changes, and documentation for regulatory adherence.

Responsibilities

• Represent regulatory functions within product development and manufacturing teams.
• Prepare and manage submission documentation for global regulatory agencies.
• Interact with regulatory bodies during review processes and audits.
• Provide guidance on regulatory contingency planning.
• Monitor and interpret evolving global regulations and guidance.
• Review product labeling, documentation, and change control for compliance.

Requirements

• Bachelor's Degree and at least 3 years of related experience or equivalent.
• Formal training in regulatory affairs or related fields.
• Preferred: Degree in sciences such as Biology, Microbiology, Chemistry, or Bioengineering.
• Experience with domestic and international product submissions.

Skills

• Strong knowledge of global medical device regulations, especially for Class II and III devices.