Regulatory Affairs Specialist- EBD

hace 4 semanas

Barcelona, Barcelona, España Divurgent A tiempo completo

Job Details:

Regulatory Affairs Specialist- EBD

Vacancy Name: Regulatory Affairs Specialist- EBD

Vacancy No: VN309

Employment Type: Full-Time

Location: Not Specified

About the Job

Sinclair is looking for a Regulatory Affairs Specialist to manage global product registration and regulatory approvals for Energy-Based Devices (EBD). In this role, you will ensure compliance with international regulatory authorities and support market entry for EBDs worldwide. You will collaborate with cross-functional teams to maintain and submit regulatory approvals, driving the successful launch of products in global markets.

This is an exciting opportunity to contribute to the efficiency and effectiveness of regulatory processes while ensuring alignment with global standards and business objectives.

Key Responsibilities
  • Prepare, submit, and manage regulatory applications for Energy-Based Device (EBD) product registrations, amendments, renewals, and post-approval changes in assigned countries based on company priorities.
  • Coordinate with cross-functional departments to gather and compile necessary documentation for product registrations, ensuring compliance with country-specific regulatory requirements.
  • Monitor and interpret international regulatory requirements for EBD product registrations, providing strategic advice and assessing operational impacts.
  • Advise on jurisdiction-specific regulatory requirements, ensuring that these are communicated and incorporated into the design inputs and development processes of new and existing products.
  • Maintain up-to-date records of registration statuses, submissions, and communications with regulatory authorities and involved stakeholders, including distributors and importers.
Requirements
  • Bachelor's degree in Life Sciences or related field, or equivalent work experience in regulatory affairs with a focus on medical device product registrations.
  • 3+ years of experience in Regulatory Affairs within the Medical Devices industry.
  • Proficiency in computer skills, including but not limited to Windows and MS Office.
  • Full proficiency in English is required.
  • Expertise in regulatory pathways and documentation requirements for device registrations.

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