Seeking an experienced quality professional that specializes in Regulatory Compliance, specifically to FDA medical device guidelines, ISO9001/13485, EU MDR and 21CFR820 codes. The primary responsibility of the position is to monitor and review industry standards while helping maintain a quality program that strives for continuous improvement.
- Maintain continued awareness of emerging reporting requirements (worldwide).
- Develop, implement, and maintain all aspects of an effective quality management system that meets the requirements of the FDA QSRs, 21 CFR PART 820, ISO 9001, ISO 13485, the EU MDR, and other applicable standards as identified for commercialization of medical devices.
- Responsible for regulatory and quality aspects related to design, development, manufacturing, registration, and commercialization of medical device products. This position will work in a team environment, interacting with all departments, Engineering, Operations and Marketing.
- Coordinate and prepare all US and International regulatory submissions, including coordination with regulatory agencies for any pre-submission strategies, as necessary.
- Participate in regulatory/customer audits.
- Perform on-site supplier audits when necessary.
- Assesses customer complaints for potential regulatory reporting, based on product specific criteria. He /she verifies assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling.
- Working as part of a cross-functional team, ensure that products are designed, developed, and manufactured in accordance with internal procedures and meet the requirements set forth in the applicable regulations and standards including performance testing requirements.
- Develop and implement with Engineering & Marketing the corporate regulatory strategies for new products and marketed products based on US, EU and other International standards, regulations, legislations, and guidance.
- Develop and monitor supplier performance program according to company policies, including on boarding new suppliers and managing current suppliers, audit according to supplier quality agreements.
- Implement company feedback and monitoring and measuring programs with quality team (e.g. CAPA, NCR, Complaints, Internal Audits) according to company policies and regulatory requirements, ensuring reportability and field action assessments are made and reported appropriately including regulatory authority reporting.
Depending on experience, the Specialist will have a working knowledge of medical device quality management system regulations and guidance. The individual should have some experience in best QMS practices with a view to end-user satisfaction and international regulatory expectations.
- BA/BS required.
- ASQ Certifications preferred.
- Minimum 3-5 years of compliance-focused education and/or experience working within medical device manufacturing quality management systems.
- Strong familiarity with 21 CFR Part 820, ISO 13485, and EU MDR.
- Experience in quality assurance processes (root cause, risk assessment, CAPA).
- SME in FDA, ISO, EEO Regulations
- Reliable self-motivated, leadership, and training skills.
- Strong communication skills – both written and verbal.