ur client, a medical device company based in Cork are seeking a Quality and Regulatory Assurance Specialist. The candidate will be responsible for the development and maintenance of an ISO 13485 quality management system, preparing regulatory submissions and annual reporting for medical devices. The candidate should have a hands‐on approach to projects with a good attitude and work ethic. They must also have the ability to work in a flexible and small entrepreneurial environment is essential and there is an excellent package available for the right candidate.
• Manage all regulatory affairs activities in support of medical device product development,
• including clinical, preclinical, and marketing issues
• Support planning, preparation, and submission of regulatory medical device submissions,
• including IDEs and 510(k)s
• Provide strategic regulatory insight to team members regarding product development plans
• Manage interactions with FDA and other regulatory authorities.
• Monitor global regulatory trends and requirements impacting the development and
• commercialization of products, and advise colleagues and external partners to ensure
• Participate in formulating strategies to optimize product approvals and opportunities of new
• and existing products, based on a broad understanding of regulatory requirements
• throughout the global marketplace for diagnostics and other medical device products
• Maintain regulatory filings and compile all documentation needed for annual reporting and
• approval supplements
• Managing the preparation of registration packages and responses to deficiency letters
• Negotiating submission data requirements and deliverable dates with regulatory authorities
• and internal technical teams
• Acting as a point person for regulatory agency interactions (either written or oral), including
• preparation of briefing packages and strategy for meetings, inspections, advisory committee
• meetings, and responses to agency letters pertaining to the assigned products/teams
• Evaluating manufacturing and labelling changes, and promotional materials for regulatory
• impact and to ensure compliance with applicable regulations
• Maintaining awareness of global regulatory legislation and assess its impact on business and
• product development programs
• Implement, gain approval for and manage an ISO 13485 quality management system.
• Main point of contact for notified body during certification and audits.
• Keep abreast of changes in domestic and international Quality Systems regulations and
• guidelines, and advise key staff of compliance/non‐ compliance with current international
• regulations, policies and EC directives
• Minimum of 4 years’ experience in regulatory and quality affairs in a medical device
• Thorough understanding and knowledge of FDA Quality System regulation, ISO 13485 and
• 21CFR820, ISO 14971, MDD (93/42/EEC).
• Proven track record in writing major regulatory device submissions (i.e. CE certification, IDEs
• and 510(k)s), with the ability to successfully manage projects to deadlines
• Experience working directly with regulatory agencies
• Previous domestic/international submissions experience.
• Experience of clinical trials a plus
• Strong ability to manage critical projects as part of an interdisciplinary team
• Excellent problem solving and communication skills
• Must be self‐motivated and detailed oriented
• Excellent oral and written communication skills
• Ability to work as part of multi‐disciplinary team of clinicians, engineers and senior
• Regulatory Affairs Certification (RAC) is desirable.
If you would like further Information you can contact the recruiter directly:
Oran McIvor | Tel: +353 (0) 1 507 9270