Senior Regulatory Affairs Specialist

16 hours ago

Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €60,000 - €95,000

**Job Title:** Senior Regulatory Affairs Specialist

About the Role

This is a unique opportunity to join our team as a Senior Regulatory Affairs Specialist, where you will play a key role in ensuring compliance with global regulations and guidelines for medical devices. As part of our regulatory affairs team, you will be responsible for post-market activities, including adverse event reporting, complaint monitoring, and risk management.

In this challenging and rewarding role, you will work closely with cross-functional teams to support timely and quality regulatory submissions and approvals globally. You will also maintain knowledge of current US, EU, and international regulations/guidelines/policies related to medical devices, and provide guidance on their application within our organization.

Key Responsibilities:

  • Complete global Post Market Surveillance (PMS) activities and assignments for Administration and Safety System medical devices in our portfolio.
  • Support establishment and maintenance of procedures, work instructions, and templates associated with PMS activities.
  • Responsible for complaint monitoring and adverse event reporting globally.
  • Author with guidance to create PMS Plans, PMS 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 along with supporting the maintenance of appropriate Design History File (DHF) documents and Risk Management Files (RMF).
  • 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.
  • Collaborate with cross-functional team members in collecting, reviewing, and analyzing, and reporting on safety and performance data to identify potential adverse safety risks or performance trends.

Requirements

To be successful in this role, you will require a strong understanding of global device regulations, policies, and guidelines, particularly in relation to medical devices. A Bachelor's Degree in science, math, engineering, or a related discipline is essential, while a Master's or PhD degree is highly desirable. Additionally, you will need 5+ years of experience in medical device regulatory affairs, preferably with a focus on post-market activities.

As a Senior Regulatory Affairs Specialist, you will possess excellent analytical and communication skills, with the ability to interpret complex regulatory requirements and communicate these effectively to stakeholders. You will also have advanced knowledge of computer software packages, including MS Word, MS Excel, MS PowerPoint, SharePoint, MasterControl, Adobe, and MS Teams.

Benefits

We offer a competitive salary and benefits package, including comprehensive training and development opportunities. As a valued member of our team, you will enjoy a collaborative and dynamic work environment, with the opportunity to contribute to the success of our business. In addition, we provide ongoing professional growth and development, as well as recognition for outstanding contributions.

Other Information

This role requires occasional travel, typically up to 13 business days per year. If you are a motivated and experienced professional seeking a new challenge, we encourage you to apply for this exciting opportunity.

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