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

We are seeking an experienced and highly organized Program Manager to oversee a critical remediation effort in response to regulatory findings received by our client. This position is vital in leading the cross-functional teams in addressing assessments and compliance gaps and implementing corrective actions to resolve the issues highlighted by the overseeing regulator. The dynamic Program Manager will be responsible for managing the overall remediation plan, ensuring timely and effective execution, and maintaining continuous communication with both internal and external stakeholders, including regulatory agencies. This is a remote role with the ability to travel domestically as required to support project needs.

What You Will Do

• Lead the end-to-end remediation efforts to address the issues outlined by the regulatory findings, including root cause analysis, corrective actions, and preventative measures coupled with developing/executing a detailed remediation plan with timelines, deliverables, and resources
• Work closely with teams in Quality Assurance, Regulatory Affairs, Engineering, Manufacturing, and other departments to implement the remediation plan effectively. Ensure alignment across teams and ensure timely issue resolution
• Maintain ongoing communication with the regulatory bodies, providing status updates on corrective actions and ensuring compliance with regulatory timelines. Prepare responses to inquiries, including documentation and required reports
• Proactively identify, assess, and mitigate risks associated with the remediation process. Develop and implement strategies to address any new or evolving risks
• Ensure all remediation actions are well-documented, compliant with regulatory requirements, and meet internal quality standards. Oversee the preparation of documents such as CAPA (Corrective and Preventive Actions), regulator correspondence, and audit reports
• Monitor progress against the remediation timeline and escalate any issues or delays to senior management. Provide regular updates and progress reports to internal leadership and external regulatory bodies as needed
• Lead and motivate cross-functional teams, ensuring high levels of collaboration and focus on delivering results. Conduct regular meetings to track progress and resolve challenges
• Ensure that employees involved in remediation efforts are adequately trained and informed about regulatory requirements, procedures, and compliance standards
  
  

What You Will Bring

• Bachelor's degree in Life Sciences, Engineering, Quality Management, or related field is required. A master’s degree or relevant certifications (e.g., PMP, ASQ) is preferred
• 10+ years of experience in program management or project management, with a minimum of 5 years in the medical device industry
• Proven experience in regulatory remediation efforts coupled with in-depth knowledge of regulations (ISO 13485, 21 CFR Part 820, 21 CFR Part 803, etc.) and other applicable regulatory standards
• Strong project management skills, with the ability to manage multiple, complex projects simultaneously
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization
• High level of attention to detail and organizational skills along with the ability to analyze complex regulatory issues and propose effective solutions
• Ability to work under pressure and meet tight deadlines in a highly regulated environment
• Familiarity with quality management systems (QMS), risk management, and CAPA processes
  
  

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.