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Job #03649

About our client Our client is a privately held medical device company based in MA that is focused on the development and commercialization of surgical equipment for the medical and dental industry. The company has an experienced management team, over 10000 products, and an empowering culture that is focused on the long-term development of its employees. Position Location Director of Quality Assurance/Regulatory Affairs Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the quality systems to ensure compliance with GMP, regulatory agencies, client and corporate expectations 2) Oversee quality system activities including documentation control, internal audits, quality records maintenance and management Review 3) Interface with US and International compliance and certification authorities as necessary 4) Function as Management Representative accountable for implementing and maintaining a compliant quality system as per regulatory requirements 5) Represent the company during medical device regulatory agency audits and inspections 6) Ensure that the company has effective systems which result in compliance with medical device regulations and standards and for the completeness and quality of regulatory submissions 7) Identify and implement continuous improvements for the quality system 8) Maintain excellent working relationships with the FDA, other regulatory agencies, internal project team members, collaborators/partners and contract manufacturers Requirements 1) Degree (4 year) 2) Minimum 5 years of leadership experience in medical device QA/RA (GMP) environment 3) Minimum 10 years of experience in QA and regulatory compliance 4) Experience in leading both FDA and internal audits 5) Proven experience in implementing and improving quality management systems 6) Strong knowledge of FDA (510k) and ISO 13485 regulations and guidelines