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Senior Technical Compliance Specialist

2 weeks ago

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

Are you ready to make a difference in the world of medical devices?

Job Title

We are seeking a Principal Device Technical Regulatory Specialist to join our team.

  • This role involves being a Subject Matter Expert (SME) in the application of FDA, EU and ISO standards, regulations and guidance related to design control and regulatory compliance.
  • Maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to our development programs.
  • Actively collaborate within both the Technical Regulatory function and wider GDD on the development of regulatory strategies for combination products and medical devices.
  • Lead project teams in their awareness of current regulatory best practice when building device development plans.
  • Provide mentoring for, and support the development of, the Technical Regulatory team.
Key Responsibilities

The Principal Device Technical Regulatory Specialist will be responsible for:

  1. Providing expert advice to the EU regulatory function in relation to the device constituent of Drug Device Combination products in accordance with the Medical Device Regulation (MDR) and associated European Medicines Agency (EMA) guidance's.
  2. Leading the program team in the implementation and execution of strategies and plans that ensure compliance to regulations, legislations, standards, and regulatory guidelines.
  3. Collaborating within program teams to ensure regulatory strategies are disseminated and understood and aligned with the key milestones and critical path activities of the program.
  4. Generating regulatory plans (e.g., meeting requests, submissions etc.) which are aligned with the overall program level timelines.
  5. Driving the authoring and review of documents for regulatory submissions; including, but not limited to, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), Marketing Authorisation Applications (MAAs), variations and other related activities (e.g., meeting requests, planning, and execution).
About This Role

We are looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

  • Bachelor's degree in a scientific/engineering discipline. A master's or higher degree desirable.
  • Proven experience in pharmaceutical and/or medical device development.
  • Advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements regulatory plans and high-level strategy planning including but not limited to 21 CFR 820 and MDR (EU) 2017/745.
  • Knowledge of global Medical Device and Drug-Device Combination Product quality requirements including but not limited to device design controls in accordance with ISO 13485 and 21 CFR.
  • Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant proportion having a drug delivery/device focus.
  • Experience, at a team level, in device development programs, specifically with a focus on the preparation and delivery of technical regulatory strategy and content.
  • Demonstrable track record of competence in leading device program teams in problem solving approaches to technical regulatory issues. People management experience a distinct advantage.
  • Knowledge of the impact of device manufacturing processes in device development.
  • Excellent communicator; clear and concise in communications, both written and verbal.
  • Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the department.
  • Proficiency in speaking, comprehending, reading, and writing English is required.
Benefits

We offer a competitive salary, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

  • Excellent career progression opportunities
  • Work-life balance initiatives
  • Bonus scheme
  • Health insurance
  • Pension
Sustainability

We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve.

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