Sr. Regulatory Compliance & PMA SME - Medical Device #0593 Enhanced Compliance Inc. - 3.6 Danvers, MA Job Details Full-time 8 hours ago Qualifications Quality control corrective actions FDA submissions Controlling experience Technical documentation Preventive action implementation Legislative impact assessment Compliance audits & assessments Corrective and preventive actions (CAPA) Collaboration with product development teams Compliance documentation Quality compliance management Document review Technical writing Internal compliance assessments Regulatory submission editing and review Design controls Biomedical regulatory compliance Regulatory compliance analysis Senior level Cross-functional communication Full Job Description About ECI ECI's mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. About the Role The ideal candidate will provide senior-level regulatory affairs and quality compliance support within an ongoing remediation program for Class III medical devices. The consultant will serve as a subject matter expert responsible for reviewing design change regulatory impact assessments, evaluating potential impacts to PMA/510(k) submissions and associated regulatory documentation, identifying compliance gaps, and supporting remediation activities. What We Look For Extensive medical device Regulatory Affairs experience, with significant PMA/Class III experience Strong knowledge of PMA post-approval requirements and 510(k) regulatory requirements Demonstrated experience reviewing design changes and regulatory impact assessments Ability to independently review existing PMA/510(k) submissions and compare approved/cleared configurations against proposed or implemented changes Experience determining whether design changes require regulatory submission or other regulatory action Strong understanding of Quality Systems and Design Controls Experience with compliance remediation, gap assessments, CAPA, document remediation and/or FDA inspection remediation Familiarity with medical device software and software-related design changes Strong ability to identify incomplete, inaccurate or inadequately justified regulatory assessments Ability to work cross-functionally with Regulatory, Quality, Engineering and R D teams Strong written documentation and technical/regulatory rationale skills Comfortable operating independently in a high-priority remediation environment ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.