Headcount Solutions Ltd

<< Back

Senior Regulatory Affairs Specialist

Reference ID : NHC04
Category :
  • Pharma / Biotech
  • Science
  • Medical Devices
Date Posted : Apr 1, 2020
Job Location
  • Munster
- Limerick
Experience : 5+ Yrs
Salary : Neg
Employment Type
Nicola O'Sullivan
Contact Number : +353870622429
Senior Reg Affairs Specialist required for renowned Med Device multinational

Principal Responsibilities

We are actively seeking to recruit an experienced Regulatory Affairs Specialist to cover a maternity leave within a leading Munster based Medical Device multinational.

The successful candidate will supervise a Regulatory Affairs team to ensure that it runs in a smooth and efficient manner.

This is an excellent opportunity to progress your career within a renowned organisation.




  • Responsible for supervising the day to day workload and operational issues of the regulatory affairs team.
  • Co-ordinate the day to day running of the regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
  • Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required and other jurisdictions as required.
  • Actively pursues ways in which to improve the function of the Regulatory Affairs Department.
  • Highlights any updates to regulatory requirements to Senior Management.
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
  • Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
  • Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
  • Advise other Cook functional units (engineering, marketing, operations, quality etc.) of the requirements in each target market and updates same on approval status in target markets.
  • Ensures the biocompatibility and clinical requirements of the product are adequately addressed.
  • Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
  • Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
  • Maintains a system for registration information (license numbers, expiration dates etc.) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.

Qualifications & Requirements


  • Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable.
  • Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.
  • Knowledge of requirements in other jurisdictions where required.
  • Knowledge of medical device quality standards/practises or similar regulated industry.
  • Good communication and inter-personal skills.
  • Proven problem-solving skills.
  • Good computer skills including knowledge of Microsoft® Office.
  • Proven organisational skills.
  • High self-motivation.
  • Approved External Auditor.
  • Willingness and availability to travel on company business.

For more information contact Nicola on 0870622429 or email your details in the strictest confidence to jobs@headcount.ie

Apply Online

To apply for this opportunity, simply add your details to the form below and upload your CV (in word document format). One of our specialist consultants will contact you to acknowledge your application to discuss the opportunity further.
Your Name *  
Contact Number *  
Email Address *   
Upload CV
Additional Notes