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

ECI; Danvers (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

ECI is seeking a senior Regulatory Affairs professional to support remediation for Class III devices. You will review PMA/510(k) submissions, assess design changes, and ensure compliance across Quality Systems and Design Controls.

The role requires cross-functional collaboration with Regulatory, Quality, Engineering and R&D teams, and the ability to operate independently in a high-priority remediation environment.

Qualifications

• Extensive Regulatory Affairs for medical devices with PMA/Class III.
• Strong knowledge of PMA post-approval and 510(k) requirements.
• Experience reviewing design changes and regulatory impact assessments.
• Ability to compare PMA/510(k) submissions with approved configurations.
• Experience determining if regulatory submissions are required.
• Solid understanding of QS and Design Controls.
• Experience with remediation, gaps, CAPA, and FDA inspections.
• Familiar with medical device software and software-related changes.
• Ability to identify incomplete or unjustified assessments.
• Proven cross-functional collaboration with Regulatory, Quality, Eng, R&D.
• Strong written documentation and regulatory rationale skills.
• Comfortable working independently in high-priority remediation.

Responsibilities

• Provide senior regulatory affairs and quality compliance support in an ongoing remediation program for Class III devices.
• Review design changes and regulatory impact assessments; advise on regulatory actions.

Skills

PMA / Class III

Regulatory Affairs

Impact assessments

Design Controls

Cross-functional

Documentation

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.

Brief 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.