Ref No: AM17007
Limerick, Co. Limerick, Ireland
Senior Regulatory Affairs Specialist - Limerick.
In this role you will assist in the running of the Regulatory Affairs (RA) function. You will provide technical input into regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. Provide regulatory affairs support for the 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, EU-MDR 2017/745 and FDA 21CFR Part 820, and other jurisdictions as required.
• Maintain an excellent understanding of the global medical device regulations related to Class 2a, 2b, 2b implantable and Class 3 Drug Device products and how these regulations apply to the company's products.
• Maintain an excellent understanding of the applicable standards, harmonised, ISO, ASTM etc. related to the products.
• Highlight any updates to regulatory requirements with regulatory management and work with the applicable stakeholders to develop a strategy to implement any subsequent changes.
• Develop global regulatory strategies for the medical devices in collaboration with other regulatory affairs or clinical personal, especially on high-risk devices.
• Advises other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and update same on approval status in target markets.
• Works with other functional units (engineering, marketing, operations, quality etc.) to ensure that the relevant documentation (Design Reviews, Process qualifications, Protocols and reports etc.) are adequate to meet the relevant regulatory need.
• Provide subject matter expertise and guidance related to applicable regulatory requirements, including but not limited to Clinical evaluation reports (CER MEDEV 2.7.1 Rev 4), Post Market surveillance (Post Market Clinical) Follow Up and Periodic Safety Update Reports, Design Dossiers, Risk Management Files, Biocompatibility, Sterilisation and Product Labelling.
• Plan and prepare regulatory submissions for specific target markets for new products, product changes and re-registrations as needed.
• Liaise and negotiate with the Notified Bodies, Competent Authorities, FDA etc. to ensure that planned actions will satisfy the regulator's expectations.
• Co-ordinate multiple projects and communicate status of projects/submissions directly to RA Management and other stakeholders as required.
• Act as a liaison on regulatory issues between the the company and the local office and/or distribution partner.
• 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.
• Provide support to currently marketed products as necessary including input on change requests, etc.
• Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations.
• Provide regulatory support to functional units such as the SSC, tenders, customer quality and distribution.
Qualifications and experience sought:
• Third level Qualification in Science/Quality.
• 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, EU-MDR 2017/745 and FDA 21CFR Part 820
• Knowledge of requirements in other jurisdictions.
• Knowledge of medical device quality standards/practises or similar regulated industry.
• Good communication and interpersonal skills.
• Proven problem-solving, prioritisation & organisation skills.
• Good computer skills including knowledge of Microsoft