Regulatory Affairs Specialist

2 days ago

Singapore beBeeCompliance Full time $80,000 - $150,000
Regulatory Affairs Specialist - Global Compliance Expertise

Job Summary:

This is an exciting opportunity to lead and manage regulatory submission timelines for new and existing products across key global markets.

  • Establish and manage regulatory submission timelines for new and existing products across key global markets, ensuring compliance with international regulations, standards, and directives.
  • Prepare and file global medical device applications and amendments to facilitate timely market access.
  • Engage with regulatory authorities and distribution partners to support product registrations, enhancing collaboration and communication.
  • Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
  • Conduct global regulatory impact assessments for product and manufacturing changes through the document control process, preparing and submitting required regulatory updates.
  • Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
  • Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance.
  • Review and approve product labeling to ensure compliance with global regulatory requirements.
  • Support and participate in inspections and audits conducted by global regulatory authorities, fostering a culture of continuous improvement.

Requirements:

  • Minimum 5 years of experience in Regulatory Affairs, with a proven track record of successfully managing regulatory submissions and collaborations.
  • Fluent English language skills, with excellent written and verbal communication abilities.

Why You'll Thrive Here:

This role offers a unique opportunity to leverage your expertise in regulatory affairs to drive business growth and success. As a member of our team, you'll be empowered to make a meaningful impact and contribute to shaping the future of our industry.

What We Offer:

• Competitive compensation package

• Opportunities for professional growth and development

• Collaborative and dynamic work environment

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