Regulatory Affairs Specialist II #1444

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 Regulatory Affairs Specialist III is responsible for supporting regulatory strategy, preparing submissions, and ensuring compliance with applicable domestic and international regulations. This role works cross-functionally with quality, R&D, clinical, manufacturing, and marketing teams to support product development and commercialization activities.

Workplace Model: This role is remote, with 10% travel to office in Carlsbad, CA. Local candidates ideal.

What you'll do

• Conduct regulatory assessment and remediation activities supporting the integration of products into the clients systems and standards.
• Perform gap assessments of existing regulatory documentation, including:
  • Letters to File
  • Change assessments
• Generate and remediate Regulatory Assessment / Letter to File documentation to ensure:
  • Proper justification of product changes
  • Alignment with 510(k) regulatory requirements
  • Compliance with internal BSC documentation practices
• Evaluate and document product changes and improvements, including:
  • Regulatory impact assessments
  • Change control documentation
  • Standards-based gap analysis
• Support Design History File (DHF) updates and remediation activities within the Boston Scientific documentation management system.
• Participate in cross-functional project teams, including:
  • Sitting alongside technical and program leads
  • Providing regulatory input on product, software/firmware, and system-level changes
  • Reporting regulatory findings and risks back to broader program stakeholders
  • Support advertising and promotional material review using BSC’s APPROVE system to ensure compliance with applicable regulatory requirements.
  • Collaborate with engineering and quality teams on implantable Class II system devices, including software and firmware components.
• Provide regulatory support aligned to a U.S.-focused regulatory strategy
• Contribute to program-level regulatory activities (e.g., ATLAS program) as needed.
• Other activities as reasonably determined and agreed upon by project liaisons.

What We Look For

• Bachelor’s degree in engineering, science or regulatory affairs preferred
• Experience with Class II (510(k)) devices
• Experience with implantable systems (preferred)
• Experience with regulatory assessments, letters to file
• Change control and impact assessments
• Gap assessments (documentation + standards)
• Experience supporting software and/or firmware-controlled devices
• Familiarity with advertising/promotional review processes (ideally APPROVE system)
• Ability to operate in cross-functional team environments
• Ability to communicate effectively in written and oral Form. Excellent report writing skills essential.
• Ability to find a solution or deal proactively with work related problems.
• Ability to develop and sustain positive relationships with internal as well as external customers.

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.