Regulatory Affairs Manager
Regulatory Affairs Manager
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Job Description
We are seeking a dedicated Regulatory Affairs Manager to join our team in Tipperary Ireland. This is an exciting opportunity to work with a world-class team and contribute to our reputation for excellence in the IVD industry. In this strategic and hands-on leadership role you will lead our Regulatory Affairs function ensuring global compliance and successful product registration in alignment with evolving regulatory standards.
You will drive the implementation of our regulatory strategy oversee both EU and international submissions (with a strong focus on IVDR) and serve as the designated Person Responsible for Regulatory Compliance (PRRC) under IVDR Article 15.
Key Responsibilities
- Lead and manage the Regulatory Affairs team aligning regulatory activities with business objectives and operational timelines.
- Oversee day-to-day workload planning and prioritisation of regulatory tasks in coordination with site operations.
- Define and communicate registration requirements for Technopath products across target global markets.
- Drive CE marking activities in accordance with the In Vitro Diagnostic Directive (IVDD) and In Vitro Diagnostic Regulation (IVDR).
- Manage international product registrations working with internal teams and external regulatory partners.
- Maintain up-to-date records of registration status notifications and certifications.
- Prepare and submit product registration documentation for markets outside the EU.
- Ensure the organisations regulatory library is current including applicable EU Directives ISO standards CFRs and FDA guidance.
- Maintain existing product registrations to avoid supply disruptions.
- Provide regulatory input and approval for changes impacting the Quality Management System (QMS).
- Prepare and maintain Technical Files to support EU and international regulatory submissions.
- Respond to regulatory authority requests and manage regulatory inspections as needed.
- Conduct post-market surveillance (PMS) reviews and ensure ongoing compliance with reporting requirements.
Qualifications :
- Degree (or higher) in a relevant field such as Science Engineering or Quality Assurance.
- At least 5 years experience in Regulatory Affairs within the IVD or medical device industry.
- Strong working knowledge of key regulatory frameworks: FDA 21 CFR 820 ISO 13485 ISO 14971 IVDD 98/79/EC and IVDR (EU) 2017/746.
- Eligibility to act as PRRC in accordance with IVDR Article 15.
- Proven ability to manage product registrations across multiple regions.
- Leadership experience is desirable with a demonstrated ability to develop and support high-performing teams.
- Excellent written and verbal communication skills.
- Diligent with strong organisational and prioritisation abilities.
Additional Information :
Our values
- PASSION
- CURIOSITY
- INTEGRITY
- BRILLIANCE
- RESPECT
Benefits
- 25 days holidays
- Life assurance & health allowance
- Discounts with local and national retailers
- Free 24/7 Employee Assistance Programme
- Recognition schemes and monetary awards
At LGC we foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process please let us know.
Join us in this outstanding opportunity to be part of a company that is leading advancements in the industry!
All your information will be kept confidential according to EEO guidelines.
Note - The PRRC shall suffer no disadvantage within the organisation in relation to the proper fulfilment of these duties.
#lgcij
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
