The Regulatory Affairs and Quality Director will support the franchise strategy and start-up efforts through oversight of all quality and regulatory requirements, ensuring that processes needed are established, implemented and maintained. Provide oversight in support of product commercialization.
- Accountable for being the management representative with responsibility and authority for the Quality Management System and regulatory requirements.
- 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; Including 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 such as 510(k) Premarket Notifications and handling any follow-up responses or actions.
- Foster 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 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, guidances, compliance dates etc.) and implement any necessary actions.
- BS in Business, Life Science, Physical Science, Engineering or closely related area is required; Master’s Degree preferred.
- 10+ years of experience in Quality Assurance and/or Regulatory Affairs at a Medical Device, Health Care, or Pharmaceutical company; demonstrated track-record of accomplishments.
- Demonstrated experience with the establishment / management of FDA Title 21 CFR 801, 803, 806, 807, 820, 821 etc.
- Experience determining regulatory strategy with FDA 510(k) submission requirements
- Proven track record of FDA Clearance(s).
- RAC Certification highly preferred
- Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communication skills
- Strong decision-making abilities
- Demonstrated hands-on capabilities as well as influencing skills with staff at all levels
- Ability to work with cross functional teams and engage with functional areas within the company.
- Energetic and excited about training team members, creating and maintaining processes, and improving quality and business processes.
- 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.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Company is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity.
- FORTUNE magazine's "World's Most Admired Companies" list for 6 consecutive years; one of only five companies to attain Most Admired status in the "Health Care, Pharmacy and Other Services" industry category.
- Fortune magazine’s Fortune 500 list
- Forbes® Global 2000
- Forbes®' America's Best Employers List for third consecutive year
- Forbes® 2019 America’s Best Employers for Women
- S&P 500
- Barron’s 500
- Member of the Dow Jones® Sustainability World Index
- Listed in the most recent Newsweek Green Rankings
- Consistently named one of the best places to work in U.S. business journal rankings
- Named a Diversity, Inc. Noteworthy Company for third consecutive year
- Listed on the Disability Equality Index® (DEI), a joint initiative of the American Association of People with Disabilities (AAPD) and the US Business Leadership Network (USBLN), recognizing companies for prioritizing the inclusion of people with disabilities
- Named Top 23 ‘Best Places to Work for LGBTQ Equality’ in New Jersey
Diagnostic Testing Services
Company is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. Their services range from routine blood tests — such as total cholesterol, Pap testing and white blood cell count — to complex, gene-based and molecular testing. They perform medical tests that aid in the diagnosis or detection of diseases, measure the progress or recovery from a disease or confirm that an individual is free from disease. In addition, they have specialized expertise in cancer, cardiovascular diseases, infectious diseases, and neurology.
In the $60 Billion and growing US Diagnostic Testing Market, Company is the leader. Company’ reputation as a leading innovator, provider of high value, low cost solutions and its financial strength and flexibility make it well positioned to capitalize on the evolving healthcare landscape.
Company’ long-term strategy is to become the undisputed world leader in diagnostic testing, information and services. To drive this profitable growth, Company plans to leverage capabilities to create differentiation:
- Deliver Innovative Solutions
- Leverage their Unparalleled Access and Distribution Network
- Expand their relationships with large payors and health systems
- Deliver Superior Patient Experiences