Senior Regulatory Affairs Professional

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €72,000 - €84,000

About Us

At West, we're a dedicated team that is connected by a purpose to improve patient lives. Our story began with solving a problem of supplying penicillin in mass quantities during World War 2.

Job Description

The Senior Regulatory Affairs Specialist will perform post-market activities for Administration and Safety System medical devices. The specialist will support departmental regulatory processes and procedures, supporting strategies for worldwide Post Market Surveillance (PMS) activities. This includes completing global PMS assignments, establishing and maintaining procedures, complaint monitoring, and adverse event reporting.

Key Responsibilities
  • 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.
  • Author PMS Plans, Reports including Periodic safety update reports (PSUR), China NMPA Periodic Risk Evaluation Reports (PRER), Canada Summary Reports, and other reports required by various health authorities.
  • SUPPORT the creation and streamline of processes to assure proactive surveillance (database searches, questionnaire) and reactive surveillance (complaints handling, field actions) is conducted accurately and efficiently.
Requirements

Bachelor's Degree in science, math, engineering, or related discipline required. 5+ years (with bachelor's degree) or 3+ years (with Master's/PhD degree) of medical device regulatory experience.

Preferred Qualifications
  • 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.
  • Knowledge of 21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDD (93/42/EEC) and MDR (2017/745) and ISO 14971.

We offer a competitive benefits package, opportunities for lifelong learning, growth and development, and an inclusive community of professionals. We also provide resources to maintain physical, mental, emotional and financial health of our team members and their families. Additionally, we are committed to creating a healthier environment and planet through sustainability efforts. If you have a special need that requires accommodation, please contact us. An offer of employment is contingent upon background screening and/or a pre-employment drug screening.

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