Regulatory Affairs Specialist 2

About the role

This role supports the implementation of regulatory strategies and submissions for smaller‑scale projects, coordinating cross‑functional efforts to ensure compliance, streamline approvals, and maintain audit‑ready documentation throughout the product lifecycle.

Key responsibilities

• Support implementation of regulatory strategies for less complex projects by collaborating with regulatory and cross‑functional SMEs.
• Assist in preparing and coordinating product submissions, conformity assessments, and change‑control processes to expedite approvals.
• Review labeling, marketing communications, and development quality reports to ensure regulatory compliance.
• Maintain documentation for regulatory filings, audits, and UDI/GTIN activities.
• Work closely with internal teams and regional regulatory partners to align on standards and support establishment registrations.
• Operate under general supervision, using independent judgment to resolve less complex issues while shadowing senior specialists.
• Stay updated on regulatory procedure changes and contribute to process‑improvement initiatives.

Required profile

• Bachelor’s degree or vocational education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
• No prior experience required with a bachelor’s degree, or a minimum of 4 years of experience in regulatory affairs, quality compliance, or product development in the medical‑devices industry.
• RAPS RAC certification is a plus.
• Fluent communication skills in English.