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Senior Regulatory Affairs Specialist

Reference ID : NHC03
Category :
  • Medical Devices
  • Pharma / Biotech
Date Posted : Aug 13, 2019
Job Location
:
  • Munster
- Limerick
Ireland
Experience : 5+ Yrs
Salary : Neg
Employment Type
:
Permanent
Consultant
:
Nicola O'Sullivan
Contact Number : 0870622429
Experienced Reg Affairs Specialist required for Limerick based Medical Device multinational.

Principal Responsibilities

Senior Regulatory Affairs Specialist

An opening has arisen for a Senior Regulatory Affairs Specialist within a Munster based Medical Device multinational, this is an excellent opportunity to advance your career within an organisation who are leaders in their field.

The successful candidate will assist in the running of the regulatory affairs function and will involve a thorough understanding of the regulatory requirements required for the Medical Device Industry.

Responsibilities:

  • Assists in the running of the regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
  • Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required and other jurisdictions as required.
  • Maintains a thorough understanding of the products assigned to the team.
  • Works to improve the function of the Regulatory Affairs Department.
  • Highlights any updates to regulatory requirements to regulatory 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 in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
  • Advise other 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 requirements of the product are adequately addressed.
  • Ensures the clinical requirements of the product are adequately addressed.
  • Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements.
  • 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

Experience and 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 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.
  • Approved External Auditor.
  • Willingness and availability to travel on company business.


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