An exclusive opportunity has arisen with a leading Medical Device SME in Galway, who are looking for a Regulatory Affairs Manager to join their growing team. The Regulatory Affairs Manager will be an integral part of the team, assuming responsibility as the key Regulatory Affairs representative for on what is a very new technology. This is a permanent position which offers flexible, hybrid working and a competitive remuneration package.
The Regulatory Affairs Manager fulfils the company’s regulatory affairs responsibilities and including:
- Assuming responsibility as the key person for RA on what is a very new technology
- Developing regulatory strategies
- Performing activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets.
- Specific emphasis on US FDA submissions
- Understanding and complying to quality, business, health & safety systems and market/legal regulations and associated Regulatory Standards
- Interfaces with other functions in a team environment providing Regulatory Affairs input & leadership.
- Maintain an excellent understanding of global medical device regulations, for specific jurisdictions, primarily in accordance with specific FDA guidance & MDD 93/42/EEC.
- Develop global regulatory strategies for the business in collaboration with regulatory affairs management.
- Plans and prepares regulatory submissions with specific emphasis on US FDA, i.e. 510(k), HDE, IDE and PMA submissions.
- Communicates directly with regulatory authorities to ensure product approvals are achieved in a timely manner.
- Maintains 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 ongoing support to currently marketed products as necessary including input on change notifications, etc.
- Ensures a thorough understanding of the products they are assigned.
- Lead the Design Review process in compliance to internal procedures including EU and FDA requirements.
- Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records.
- Ensure all product quality standards and specifications are defined and achieved in line with company and Regulatory requirements including MDD 93/42 EEC and FDA requirements.
- Lead risk management process and preparation of risk management files including Use and Design FMEAs as required.
- In conjunction with the design teams identify product testing required and write design verification and validation plans, protocols and reports including specifically advising on sample sizing; including but not limited to Ethylene Oxide sterilization, Biocompatibility, Stability and Transportation testing
- Preparation of Standard Checklists for all the applicable main harmonized standards
Skills, Qualifications & Experience:
- Minimum 8 years’ experience in Regulatory Affairs, Design Assurance or similar role in a medical device company.
- Primary and/or a postgraduate degree BS, MS, or PhD (Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field).
- Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
- Working knowledge of FDA requirements including Quality System Regulation (21 CFR 820), the Medical Device Directive (93/42/EEC) and applicable harmonised standards and the ability to apply them in practice.
- Previous experience with submissions to US FDA is a distinct advantage
For a more detailed and confidential discussion on this role contact Amy Newell.
ssuming responsibility as the key