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Senior Quality and Regulatory Assurance Specialist (QA/RA)

Job Title: Senior Quality and Regulatory Assurance Specialist (QA/RA)
Contract Type: Permanent
Location: Cork
REF: 87160
Job Published: over 1 year ago

Job Description

Contact: Jenny Dore
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 /

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