Director of RA/QA (Reg. & Qual)

Job Description:

*No recruiters please

Provides leadership to RA/QA functions for an entrepreneurial manufacturer of medical devices with marketed products and products in early-stage development. Overall responsibility for strategic and operational leadership of Quality and Regulatory, in support of AVI’s business objectives and timelines, while maintaining compliance and managing the regulatory process including all filings through Regulatory consultants and AVI’s Quality staff. This position is based in Billerica, MA, relocation is not offered.

Duties and Responsibilities:

This is a challenging and diverse role with multiple responsibilities, including, but not limited to:

• Responsible for all aspects of Quality and Regulatory planning and execution aligned with company objectives
• Oversee the required submissions and reports for all product filings and serve as primary liaison with FDA and other regulatory agencies
• Provide key contributions to defining the regulatory strategy for the successful development and maintenance of products
• Driving the creation of successful regulatory submissions and filings
• Act as Head of Compliance and Management Representative
• Manage all complaint reviews and adverse event reporting requirements originating through the customer feedback and vigilance systems and reviews. Reviews all complaints, prepares MDR and complaint closure determinations according to established procedures.
• Review and approve all promotional, advertising and labelling materials and practices to ensure accuracy and compliance with regulatory requirements, internal procedures and AdvaMed’ s Code of Ethics.
• Ensure that Design Control activities such as DHF maintenance, risk management, requirements management and traceability, design verification, design validation, and post market surveillance activities are compliant.
• Building, upgrading, and maintaining the Quality Management System (QMS) to ensure that it meets FDA cGMP/QSR, ISO 13485, the Medical Device Directive, and CMDCAS. This includes reviewing and/or writing new SOPs, oversight of CAPAs, complaints, internal and supplier audits, as well as the company’s documentation and training programs. This also includes reporting quality metrics to management during management reviews.
• Leading oversight of AVI manufacturing quality functions and supplier quality. This includes oversight of LHR documentation, quality metrics, and supplier management.
• Establish, lead, and execute Quality projects, provide day-to-day Quality direction to ensure that teams deliver on their commitments, and ensure that Quality milestones are achieved without delay.
• Ensure that Quality plans are aligned with the company's goals and accountabilities.
• Ability and willingness to be a hands-on contributor for all aspects of product development including leading the generation of risk management deliverables, review and approval
• Ensure clinical trial compliance with all regulatory regulations and standards
• Contribute to the development of the business activities
• Responsible to hire, train, manage and mentor quality staff as applicable
• Track and manage department budget actual costs vs. budget as well as provide a variance analysis of budget to actual

Qualifications:

• Bachelor’s and/or Master’s Degree in a scientific field essential
• RAC certification preferred
• Minimum of 10 years experience plus an additional 5 years of senior level experience with direct expertise in regulatory filings, clinical studies, and quality control/assurance for Medical Devices.
• Successful participation in the implementation of a quality system to ensure regulatory compliance with FDA and international quality standards.
• Complaint handling within an FDA/CE environment and MDR reporting.
• Effective negotiation and decision-making skills
• Development and preparation of successful regulatory strategies and ability to write and defend such strategies
• Experience in registration of sterile products
• Experience actively participating in product development teams
• Thorough knowledge of GMPs, GLPs, GCPs, ICH guidelines, US regulatory guidelines and ISO regulations/standards
• Working knowledge of EU and Canadian regulations. Direct experience in supporting startup of International market entries a plus.
• Proficiency in the use of PC and programs, particularly Excel, Word, PowerPoint.
• Excellent written, verbal and presentation communication skills and organizational skills.
• Ability to originate and complete projects with little to no oversight.
• Ability to interact successfully with multiple internal stakeholders.
• Expert knowledge of application of all regulatory regulations and guidelines pertaining to clinical trials
• In depth knowledge and understanding of all phases of clinical trials
• Ability to manage multiple projects simultaneously
• Analytical thinker with problem solving skills and ability to adapt to changing priorities