Head of Regulatory Affairs & Quality Assurance to work on-Site in Lompoc, CA (relocation assistance provided)
For over 40 years, we have been a leader in high-quality dental products sold to dental professionals around the world. We manufacture and assemble the majority of our products at our world headquarters located on the beautiful Central Coast of California. Our expansive product portfolio includes: Restoratives, Impressions, Whitening, Oral Hygiene, Magnification and Illumination, and Small Equipment. In addition, our lab offers several well-known brands that patients ask for by name, and we recently introduced a clear aligner solution.
The Head of Regulatory Affairs & Quality Assurance will oversee the Regulatory & Quality Assurance departments and develop and implement department goals, objectives, and systems to ensure compliance with Quality System regulations established by internal procedures, the US FDA and applicable international regulatory bodies and/or standards.
Head of Regulatory Affairs & Quality Assurance Responsibilities:
- Coordinate activities in quality assurance, product returns, and regulatory to ensure compliance with all applicable regulatory requirements and achievement of company objectives as well as resolve problems; work with other departments to accomplish the same.
- Plan and direct the organization's Quality Systems and Regulatory policies, objectives, and initiatives.
- Plan, direct and document the review of the suitability, effectiveness and adequacy of the organization's Quality System.
- Manage the Quality Assurance Program in accordance with FDA Quality System Regulations (QSRs) and ISO 13485 Quality Systems. Serve as the Company's Management Representative and Person Responsible for Regulatory Compliance (PRRC), and be the lead contact for all regulatory agencies, notified bodies, and international representatives, including but not limited to MDSAP and EU-MDD/MDR countries.
- Ensure that quality system requirements are maintained and report to Management with Executive Responsibility on the performance of the Quality System.
- Develop, implement, and maintain processes used in the design, manufacture, and service of devices and assure that they are adequate, in support of and aligned with company objectives and in full compliance with regulatory requirements.
- Recommend and approve changes to the Quality System as necessary to ensure compliance with FDA/ISO/EN/MDD/CMDR & CE marking requirements.
- Lead, direct, coordinate and maintain the process for creation and maintenance of product design dossier/technical files.
- Communicate changes to the Quality System and/or to product requirements, defined in the Design History File, Design Dossier, and/or Technical Files to the applicable Notified Body.
- Direct and prepare regulatory documentation for submission to regulatory agencies inside and outside the United States, specifically key International markets including but not limited to Canada, the EU, Asia Pacific, the Middle East, Latin America and Australia to achieve product registrations. Manage/coordinate domestic and international submissions, compliance efforts, labeling review, and product development as required.
- Prepare reports and summaries such as regulatory positions, statements, and interpretive abstracts of reports to be submitted to the FDA.
- Provide leadership in establishing regulatory policies and procedures in full compliance with FDA and Canadian regulations.
- Provide leadership for timely and effective submissions leading to product approvals for marketing in the U.S. and Canada.
- Preserve the rights of the Corporation when acting as liaison between the Corporation and the FDA.
- Maintain verified accredited wholesale drug distribution certification (VAWD) in all 50 states within the U.S.
- Ensure that the Company's portfolio of both Medical Devices and Drugs are compliant with all applicable laws for manufacturing, marketing, sales and or distribution in the relevant global markets.
- Interact with local, State, Federal and international regulatory agencies.
- Keep abreast of current national and international regulations relative to the lawful sale and distribution of products. Alert executive management to any conditions required for the continued operation of the Company.
- Analyze and monitor department costs.
- Bachelor's degree is required, Master's degree preferred
- 7-10+ years of expertise in Medical Device & Pharma Manufacturing
- QMS Audit Management, Department Leadership, Process Validation Design, Product Lifecycle Management, Quality Engineering
- Clinical Studies Management experience is preferred
- Knowledge of Product Development and Regulatory Submissions such as 510(k)'s and International Registrations
- Experience Managing 483's, Pharmacovigilance, Document Control, FDA Communications, Tech File Drafting/Management, Designated Management Representative experience
We offer a competitive benefits package, including: Medical, Dental, Vision, Rx, Life/AD&D/LTD/STD, 401(k), FSA, EAP, paid vacation and sick time, and 10 paid company holidays.