Sr. Regulatory Compliance & PMA SME - Medical Device #0593

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
• Supporting remediation activities

Requirements

• 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

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.