The Senior Director, Regulatory Affairs & Quality Assurance will support the Pharma Services franchise strategy and start-up efforts through oversight of all quality and regulatory requirements, ensuring that processes needed are established, implemented and maintained. The Senior Director will provide oversight in support of Companion Diagnostics development and submissions. This position reports to the Executive Director, Medical Quality & Regulatory Affairs/Chief Lab Officer and may be based remotely within the U.S.

• Accountable for being the management representative with responsibility and authority for the Quality Management System and regulatory requirements.
• Work closely with operations, R&D, legal, manufacturing and medical teams to ensure overall project success.
• Establish effective communications with the Regulatory Affairs and Quality Assurance teams and establish clear expectations regarding project assignments, resourcing, and time management.
• Determine when external regulatory and/or quality consultant resources are required and manage the consultant efforts.
• Establish and maintain a fully compliant complaint handling process including all provisions for Adverse Event reporting (i.e., 21 CFR 803, Medical Device Reports) for all products commercialized by the company.
• Manage Change Control System for all controlled documents.
• Track, trend, & take action when necessary for supplier quality issues including initiating Corrective and Preventative Actions (CAPA’s).
• Maintain the CAPA system & hold periodic CAPA Meetings.
• Maintain non-conformity system & assure timely completion of Non-Conforming Reports (NCR’s).
• Manage audits and support regulatory inspections of contract manufacturers, vendors and test labs; this includes planning, scheduling and supporting audits to assure adherence to company quality policies and applicable regulatory requirements.
• Guide Project teams ensuring that Design Control and product requirements are met and represent the Quality/Regulatory role during the Product Development process and Design Reviews.
• Provide Quality/Regulatory perspective on Design Verification/Validation study protocols and data analysis incorporating requirements or recommendations from applicable regulatory guidance’s and consensus standards.
• Verify documentation and design controls are appropriate for organization, including design history files (DHF), device master records (DMR), standard operating procedures (SOP), and change records.
• Responsible for preparing and submitting regulatory filings to the FDA in support of product commercialization (PMA, 510K) and handling any follow-up responses or actions.
• Responsible for preparing and submitting regulatory filings to the EU and ROW (rest of world).
• Foster a Quality Excellence culture focusing on Risk Assessment and Design Control and managing deviations, CAPAs and investigations required,
• Lead recall and field action communications and reconciliation, including follow-up with US agencies.
• Responsible for the creation and facilitation of quality training initiatives for individual departments, as well as internal audit teams.
• Support purchasing and receiving controls and work very closely with suppliers of critical components and sub-systems. Participate in Supplier Audits.
• Develop inspection procedures and apply statistical techniques and appropriate sample plans.
• Ensure labeling is compliant.
• Gather, analyze, and report data reflecting status of product and processes and provide recommendations to improve such activities.
• Analyze data from customer complaints, internal audits, internal/external supplier’s data and implement appropriate solutions.
• Responsible for all medical device registrations and applicable reporting.
• Serve as key contact on FDA inquiries, site visits & registration issues.
• Establish and maintain Global Unique Device Identification Database (GUDID) & Unique Device Identifier (UDI) system.
• Document and report quality /compliance issues relating to the commercial and clinical processes and products and assume a Post-Market Surveillance responsibility.
• Lead and communicate changes in regulations and standards to ensure proper compliance through the product development to commercialization.
• Notify management of appropriate regulatory changes (e.g., new policies, regulations, guidance, compliance dates etc.) and implement any necessary actions.

• A minimum of 10 years of experience in Regulatory Affairs and/or Quality Assurance at a Medical Device, Health Care, or Pharmaceutical company, with a demonstrated track-record of accomplishment and success.
• Demonstrated experience with the establishment / management of FDA Title 21 CFR 801, 803, 806, 807, 820, 821 etc.
• Experience determining regulatory strategy with FDA PMA and/or 510(k) submission requirements.
• Proven track record of FDA Clearance(s).
• A Bachelor’s degree is required. A Master’s degree is preferred.
• Regulatory Affairs Certification (RAC) is required.

Skills Required:

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of governmental regulations.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures.
• Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions.