Regulatory Affairs Strategist South East/Hybrid

ICDS RECRUITMENT

Wexford

Regulatory Affairs Strategist  This is an exciting role within the Medical Device Manufacturing Industry. We are looking for an Regulatory Affairs (RA) Strategist to join a growing RA team. In this role the RA Strategist will be working with the latest technologies across a broad portfolio of products which includes PTA balloon catheters, stent grafts and active devices. This is a highly visible role within the organization, 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 onsite and flextime. 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. • Inputs 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 guidance’s 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 minimize 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 customer and support staff. • Prepare and present project updates and technical discussions. • Required to travel to EU & USA for meetings. Education and Experience. • 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. Knowledge and Skills. • 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 in CE marking according to MDR. • Good knowledge in labelling requirements and procedures. • Ability for strong attention to detail in a complex work environment with multiple and competing registration priorities. • Project management skills with good planning and organizational skills. • Basic analytical and problem-solving skills. • Basic Project Management Experience preferable. • Strong team player within RA team, other functions and international colleagues. • Excellent English communication skills are a must. • The successful candidate will have solid educational background with a degree in Science or Engineering or relevant scientific discipline with work experience in Regulatory Affairs and/or Quality Systems, preferably in the Medical Device or Pharmaceutical industry. You will have good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards. • You will have the ability for strong attention to detail in a complex work environment with multiple and competing registration priorities. Good planning and organizational skills. German knowledge is an advantage. You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business. Our Total Rewards program — which includes competitive pay, benefits, hybrid working, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates. A career here, means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfil your life’s purpose through the work that you do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-cantered, and rewarding culture.

522 days ago