EURO 40000.00 per annum
Limerick - Castletroy
My client, a leading medical device company, are currently recruiting for a Regulatory Affairs Specialist to join their team.
This is an excellent opportunity to experience an International Regulatory Affairs role with a leading medical devices Corporation, to build upon your professional knowledge of global market clearance procedures as well as of active (electro-medical) and disposable standards compliance.
Purpose of RoleThe function of Regulatory Affairs Specialist is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured and distributed to meet applicable regulatory requirements and applicable technical standards.The individual has to gain department and platform influence by co-operating in all RA accomplishments and sharing regulatory knowledge of demonstrating compliance with changing global regulations, also identifying, preparing and collecting data needed to obtain and maintain certifications and commercialization authorizations of BD products.
Essential Duties and Responsibilities
- Lead and execute OUS international product registrations attending to individual country specific requirements; monitor and report progress
- Prepare and maintain regulatory files such as STED and MDD/MDR Technical Files;
- Participation in cross-functional product development teams as the regulatory representative; development of regulatory strategies
- Engages in approval processes and monitor the relevant timelines;
- Attends to the Corporate information network, monitoring International regulatory developments to identify and communicate applicable requirements;
- Assesses changes in regulations and helps to determine their impact;
- Participate to the review of process/product changes, labeling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to International requirements;
- Attends to audits performed by internal and external authorities to represent RA positions and processes;
- Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle.
Required education and training
- BSC in Electronics or Biomedical engineering discipline, or equivalent proven experience.
Essential skills and knowledge
- Sound knowledge of the regulatory framework pertaining to Medical Devices such as the MDD CE Marking;
- Experience in International Standards in particular: ISO 13485, ISO 14971 and IEC 60601 series;
- Good working knowledge of Design Control, Software Life Cycle, Risk Mngt, V&V (e.g. BioCompatibility) processes;
- Proven regulatory affairs experience within the medical technology industry or equivalent;
- Demonstrated compliance experience with all MDD classes medical devices, possibly including (P)EMS - (Programmable) Electrical Medical Systems;
- Demonstrated experience working in cGXP environments and in new Product Development projects;
- Solid knowledge and material experience in International registrations/approval process for medical devices.
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