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Regulatory Affairs Team Lead

Regulatory Affairs Team Lead- Limerick

The primary role of the Regulatory Affairs Team Lead is to assist in running of the regulatory affairs by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas. In addition, the Regulatory Affairs Team Lead is responsible for leading a team in the RA department.
Function will involve a thorough understanding of the regulatory requirements required for the Medical Device Industry.
 
Reporting to: Senior Manager, Regulatory Affairs / Manager, Regulatory Affairs
 
 
Key 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, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required and other jurisdictions as required.
  • Maintains an excellent understanding of the global medical device regulations.
  • Maintains a thorough understanding of the products assigned to the team.
  • Works to improve the function of the Regulatory Affairs Department.
  • Understands the progress of the RA team on assigned tasks and removes roadblocks.
  • Leads a team of Regulatory Affairs Specialists / Associates.
  • Ensures the training and development needs of the team are met.
  • Provides support to the RA team members to complete assigned tasks.
  • Mentors and trains new RA team members.
  • 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 for medical devices 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.
  • Communicates status of projects / submissions directly to RA Management and other stakeholders as required.
  • Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
  • Serves as a liaison on regulatory issues between the Manufacturer and the International local office and/or distribution partner.
  • 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.
  • Provides support to currently marketed products as necessary including input on change requests, etc.
  • Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Provides regulatory support to functional units such as the SSC, tenders, customer quality and distribution.
  • Ensure that Code of Conduct is considered in all business matters carried out on the companies behalf.
  • Performs additional duties as assigned.
  • Is a delegate for the Regulatory Affairs Manager.
  • Is a delegate for the Regulatory Affairs Specialist.

Education and Experience:

  • 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, EU Medical Device Regulation 2017/745 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.
  • Previous supervisory experience, leading a team is desirable
  • 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.

 

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Job Details

Midwest
31 January 2024
Job ID: 9080

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