Regulatory Expert – Medical Devices

3 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €75,000 - €105,000

Job Description:

Senior Associate, Regulatory Affairs">

This role is a hybrid position that requires working 3 days a week onsite in Dublin. The Senior Associate will support post-market activities for Administration and Safety System medical devices, collaborating with management.

West Pharmaceutical Services focuses on delivering life-saving injectable medicines through innovative solutions.

The job description preserves the core responsibilities and qualifications of the role while removing extraneous content.

">Key Responsibilities:">
  • Complete global Post Market Surveillance (PMS) activities for Administration and Safety System medical devices in West's portfolio.
  • Develop and maintain procedures, work instructions, and templates associated with PMS activities.
  • Oversee complaint monitoring and adverse event reporting globally.
  • Author PMS plans, reports, including Periodic Safety Update Reports (PSUR), China NMPA PRER, Canada Summary Reports, and other reports required by health authorities.
  • Collaborate with cross-functional teams to analyze safety and performance data to identify risks or trends.
  • Support regulatory submissions and approvals globally.
  • Maintain adaptability to changes in responsibilities, structures, processes, or policies.
Requirements:">
  • Bachelor's Degree in science, math, engineering, or related discipline required.
  • Master's Degree in science, math, engineering, or related discipline or PhD preferred.
  • Regulatory Affairs Certification (RAC) preferred.
Preferred Qualifications:">
  • Advanced knowledge of global device adverse event/incident reporting requirements
  • Attention to detail, planning, time management, and organizational skills
  • Experience with US Class II and EU Class IIa devices
  • Knowledge of 21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDD (93/42/EEC) and MDR (2017/745)
  • International regulatory competency; strong written and oral communication skills
  • Self-motivated with a proactive attitude; able to work effectively in a fast-paced environment
Benefits:">
  • Up to 5% travel: up to 13 business days per year
  • Sedentary work; ability to occasionally lift up to 10 lbs/4 kg; sit for extended periods

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