Regulatory Affairs Strategist/ Ra Project Manager

ICDS RECRUITMENT

Wexford

Regulatory Affairs Strategist/ RA Project Manager - County Wexford (Hybrid. Our client seeks a RA Strategist to join this growing RA team. In this role the RA Strategist will be working with the latest technologies across a broad portfolio of products. This is a highly visible role within the organisation, and you will work in cross-functional teams as the regulatory medical device expert (e.g. sustaining engineering projects, new product development projects, MDR compliance program, etc.). This is a hybrid working role with at least 2 days on site. and flexi-time. Some local and international travel is also required. Key Responsibilities: • Ensures compliance with applicable Regulatory Requirements for all applicable territories in which devices are placed on the market. • Input to development of regulatory strategies and provides regulatory guidance and expertise. • Compiles and communicates regulatory requirements (e.g. MDR, FDA, International, standards, etc) to support R&D, Manufacturing & Quality to ensure systems are compliant with all internal and external guidelines. • Prepares and presents gap analysis assessments of regulations and guidances to peers and cross-functional groups in a concise and precise manner. • Reviews and approves the project documentation (design reports, labelling, etc.). • Develops tactics supporting regulatory notifications and submissions to minimise the market supply impact as a result of device changes. • Participates in product development/sustaining teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. • Preparation and submission of dossiers to regulatory authorities for CE mark and FDA approval. • Regulatory assessments of change requests and impact on global registrations. • Provide support for regulatory authority and customer audits. • Understand and follow company procedures on regulatory requirements. • Provide positive example and actively promote compliance to all standards. • Maintain a professional working relationship with internal and external customers and support staff. • Prepare and present project updates and technical discussions. Interested applicants should have: • Minimum of degree in Life Sciences or Engineering or equivalent. • Minimum of 5 – 7 years’ experience in a similar position in the medical device / pharmaceutical industry. • Have worked with regulatory submissions with exposure to implantable devices. • Knowledge and experience on EU MDR and standards (ISO 13485, ISO 14971) is a must, knowledge of FDA and international regulatory requirements is a plus. Regulatory Affairs / Quality Systems experience in the Medical Device or pharmaceutical industry. • Good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards. • Knowledge of CE marking according to MDR. • Good knowledge of labelling requirements and procedures. • Strong attention to detail in a complex work environment with multiple and competing registration priorities. • Project management skills with good planning and organisational skills.

451 days ago