Regulatory Affairs Specialist

2 weeks ago

Singapore beBeeRegulatory Full time $80,000 - $120,000
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to work effectively in a fast-paced environment.

Job Description:

  • Develop and implement regulatory strategies for new and existing products across key global markets.
  • Prepare and submit regulatory applications and amendments, ensuring timely market access.
  • Collaborate with regulatory authorities and distribution partners to support product registrations.
  • Maintain EU MDR-compliant technical documentation, including notifications of change.
  • Lead all EU regulatory initiatives.

Key Responsibilities:

  • Conduct global regulatory impact assessments for product and manufacturing changes.
  • Prepare and submit required regulatory updates.
  • Act as the regulatory representative on cross-functional teams.
  • Interpret and apply international regulations, standards, and directives.

Requirements:

  • Minimum 5 years of experience in regulatory affairs.
  • Fluent English language skills.

What We Offer:

  • A dynamic and supportive work environment.
  • Ongoing professional development opportunities.

Apply Now:

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