Telephone: 021 2066287
Senior Quality and Regulatory Assurance Specialist (QA/RA)
Who are the client
Our client, a medical device company in Cork are currently looking to recruit a Quality and Regulatory Assurance Specialist (QA/RA) for their site.
Why this role
- Excellent package for the right person
- Expanding company
- Be part of a new team
- Great location
What will I be doing
- The Quality and Regulatory Assurance Specialist will be responsible for the development and maintenance of an ISO 13485 quality management system, preparing regulatory submissions and annual reporting for medical devices.
- 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 compliance.
- 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, 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
What do I need
- 4 years' experience in regulatory and quality affairs in a medical device company.
- 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 and 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 management
- Regulatory Affairs Certification (RAC) is desirable.
For further information on this Quality and Regulatory Assurance Specialist (QA/RA) role in Cork please contact Jenny Dore on 021 2066287 / firstname.lastname@example.org
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