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Regulatory Affairs Specialist

3 weeks ago

Cork, Cork, Ireland beBeeSpecialist Full time €70,000 - €104,000
Regulatory Affairs Specialist Job

We are seeking a skilled Regulatory Affairs Specialist to join our team.

Key Responsibilities:
  • Assess regulatory intelligence to inform the development of local, regional, and global regulatory strategies.
  • Participate in advocacy activities of a technical and/or tactical nature.
  • Evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure product compliance.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
  • Identify requirements and potential obstacles for market access distribution.
  • Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
  • Evaluate proposed products for regulatory classification and jurisdiction.
  • Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
  • Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
Requirements:
  • Bachelor's degree in Engineering, Science, or related field; or Master's degree in Regulatory Science.
  • A minimum of 4 years' experience in regulatory affairs.

This is an exciting opportunity for a highly motivated and experienced professional to join our team and contribute to the success of our organization.

The ideal candidate will have excellent communication and analytical skills, as well as the ability to work effectively in a team environment.

Benefits:
  • Fully-funded contract with comprehensive benefits package.
  • Opportunities for career growth and professional development.

Location: Cork, Ireland. The successful candidate will be required to relocate to Cork, Ireland.