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Senior Regulatory Affairs Specialist

Reference ID : NHC04
Category :
  • Pharma / Biotech
  • Science
  • Medical Devices
Date Posted : Aug 13, 2019
Job Location
:
  • Munster
- Limerick
Ireland
Experience : 5+ Yrs
Salary : Neg
Employment Type
:
Contract
Consultant
:
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.

  

 

Responsibilities:

  • 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

Qualifications:

  • 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



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