Regulatory Affairs Specialist with 7+ years experience required for a permanent role with a medical device company in Co. Limerick.
- Develops regulatory strategies and provides guidance and expertise.
- Compiles and communicates regulatory requirements (e.g. MDD / MDR, standards, etc) to cross-functional groups in a concise and precise manner.
- Reviews and approves the project documentation (design reports, labelling, etc.).
- Ensures that updates to the Technical Files and international registrations are conducted appropriately.
- Develops tactics supporting first to market commercial opportunities, and minimizes time to product launch.
- Works closely with the other functions (QA, R&D, Medical Affairs…) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation.
- Identifies roadblocks, defines problems based on data / facts and effectively communicates with his/her peers, project teams or management (as appropriate) for seeking solutions.
- Supports continuous improvements in regulatory processes, QMS processes or company-wide initiatives.
- B.Sc. in Electronics or Biomedical engineering discipline
- 7+ years’ experience in Regulatory Affairs within medical devices industry with exposure to programmable electrical equipment. Alternatively a strong technical experience in the field of Programmable Electrical Medical systems including exposure to regulatory affairs requirements
- Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series…)
- Knowledge of software, instrument and disposable design practices
- Experience with representing Regulatory Affairs in multiple environments
- Strong analytical and planning skills, with the ability to make decisions and to translate those decisions into actions
- Strong communication and negotiation skills
- Ability to work in a multicultural environment
- Ability to detect opportunities for improvement and develop and implement plans
- Strong attention to detail
- Must be authorised to work in Ireland & available to travel (EU and outside EU)
- Knowledge of FDA regulatory requirements is a plus
Please contact Emer Moore to discuss in confidence