JOB OVERVIEW:
We are seeking an experienced Technical Project Manager / Project Lead
to support a critical medical device regulatory initiative. This role will focus on guiding a cross-functional engineering and regulatory team through US FDA submission processes for a modified medical product.
You will play a key leadership role in ensuring compliance with ISO 13485 standards, identifying gaps in existing documentation, and driving the team toward successful regulatory approval.
Key Responsibilities:
- Lead and mentor a multi-disciplinary team (engineering, regulatory, quality)
- Drive US FDA submission activities for medical devices (endoscopic instruments)
- Identify gaps between current product state and regulatory requirements
- Ensure alignment with ISO 13485 processes and documentation standards
- Coordinate with onsite client stakeholders and international teams
- Gather, validate, and structure evidence required for regulatory submission
- Guide teams to ensure compliance without impacting product integrity
Key Requirements:
- Proven experience managing medical device regulatory projects
- Strong hands-on experience with US FDA submission processes
- Deep understanding of ISO 13485 standards
- Ability to identify compliance gaps and drive remediation
- Experience working with cross-functional engineering teams
- Strong stakeholder management and onsite leadership capability
Please apply with current resume in Microsoft Word format only (.doc or .docx). If you would like to have a confidential discussion, please contact Bidisha Swayamprava on Bidisha.Swayamprava@davidsonwp.com, quoting reference JN -042026-43065. Want to know more about Davidson? Visit us at www.davidsonwp.com
