Ref No: AM17004
County Limerick, Republic of Ireland
Senior Regulatory Affairs Specialist - Limerick.
This role is being offered as a 22 months' fixed-term contract.
In this position you will assist in the running of the Regulatory Affairs (RA) function. You will perform activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets, provide regulatory affairs support for other functional areas and input into regulatory strategies.
Assist in the running of the regulatory affairs programs in line with internal procedures and in accordance with regulatory requirements ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820, and other jurisdictions as required.
Plan and prepare regulatory submissions for specific target markets on new products, product changes and re-registrations as needed.
Develop global regulatory strategies for high-risk medical devices in collaboration with other regulatory affairs and clinical personnel.
Advises other functions (Engineering, Marketing, Quality etc.) of the requirements in each target market, ensure the outputs from these units meet the requirements and update them on approval status of the same.
Review submissions to ensure compliance to the regulations in particular jurisdictions.
Maintain an excellent understanding of global medical device regulations and a thorough understanding of the products assigned to the team.
Support RA team members to progress and complete assigned tasks, mentor and train new team members and remove road blocks as required.
Ensure the clinical and biocompatibility requirements of the product are adequately addressed.
Communicate updates to regulatory requirements and the status of projects to RA Management and other stakeholders as required.
Communicate directly with regional regulatory agencies and notified bodies to ensure product clearances are achieved in a timely manner.
Act as a liaison on regulatory issues between the manufacturer and the local office and/or distribution partner.
Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations.
Maintain a system for registration information (license numbers, expiration dates etc) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
Act as a designee for the Regulatory Affairs Manager and perform additional duties as assigned.
Interested applicants should have:
Third level Qualification preferably in Science/Quality discipline.
At least 5 years' experience in a regulated industry in a similar role.
Knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820.
Knowledge of requirements in other jurisdictions
Knowledge of medical device quality standards/practices or similar regulated industry.
Good communication and interpersonal skills.