Senior Regulatory Affairs Expert

6 hours ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €120,000
Job Description

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in medical device regulatory affairs, with a focus on post-market surveillance (PMS) activities.

The successful candidate will be responsible for supporting the department's regulatory processes and procedures, including PMS activities, complaint monitoring, and adverse event reporting. They will also work closely with cross-functional teams to support timely and quality regulatory submissions and approvals globally.

Key responsibilities include:

  • Complete global PMS activities and assignments for Administration and Safety System medical devices.
  • Support establishment and maintenance of procedures, work instructions, and templates associated with PMS activities.
  • Responsible for complaint monitoring and adverse event reporting globally.

Requirements:

The successful candidate will have:

  • A Bachelor's Degree in science, math, engineering, or related discipline required or Master's Degree in science, math, engineering, or related discipline or PhD in science, math, engineering, or related discipline.
  • 5+ years (with bachelor's degree) or 3+ years (with Master's/PhD degree) of medical device regulatory experience.
  • Advanced knowledge of global device adverse event/incident reporting requirements.
  • Attention to detail with planning, time management and organizational skills.
  • Minimum US Class II and EU Class IIa device experience.

Benefits:

West offers a comprehensive benefits package, including:

  • Competitive salary and bonus structure.
  • Excellent health insurance coverage.
  • Paid time off and holidays.
  • Professional development opportunities.

Others:

As an equal opportunity employer, West values diversity and inclusion in the workplace. We are committed to providing a safe and healthy work environment for all employees.

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