BioTalent
PROJECT MANAGER
We're seeking a
Project Manager
to join our team at a small, innovative Class III medical device company specializing in breakthrough MedTech products. The ideal candidate is a mid-level professional with a proven track record of managing projects through design verification (DV) and regulatory submissions, specifically with 510(k) and Pre-Market Approval (PMA) experience. This role will support all company programs, from early-stage development to post-market activities, and requires a candidate who is hands-on and adept at navigating the unique challenges of a dynamic startup environment.
Responsibilities
Manage the entire project lifecycle for Class III medical devices, from initial concept through to commercialization and post-market surveillance.
Lead cross-functional teams, including R&D, Quality, Regulatory Affairs, and Manufacturing, to ensure projects are delivered on time, within scope, and on budget.
Develop and maintain detailed project plans, schedules, and budgets, while proactively identifying and mitigating potential risks.
Oversee the design verification and validation processes, ensuring all activities are meticulously documented and meet regulatory requirements.
Coordinate the creation and submission of regulatory filings, including 510(k) and PMA applications, in collaboration with the regulatory team.
Manage supplier relationships and external partners, ensuring they meet project requirements and quality standards.
Facilitate effective communication among all stakeholders, providing regular updates on project status and key milestones.
Support the development and maintenance of quality system procedures related to project management. Qualifications
Bachelor's degree in engineering, life sciences, or a related field.
Minimum of
5 years of project management experience
in the medical device industry.
Demonstrated experience managing projects through
design verification (DV) .
Proven experience with
510(k) and/or PMA submissions .
Experience with
catheter-based products
is highly preferred.
Strong understanding of
FDA regulations
and
ISO 13485 .
Experience with
supplier relations and management .
Excellent leadership, communication, and organizational skills.
Project Management Professional (PMP) certification is a plus.
We're seeking a
Project Manager
to join our team at a small, innovative Class III medical device company specializing in breakthrough MedTech products. The ideal candidate is a mid-level professional with a proven track record of managing projects through design verification (DV) and regulatory submissions, specifically with 510(k) and Pre-Market Approval (PMA) experience. This role will support all company programs, from early-stage development to post-market activities, and requires a candidate who is hands-on and adept at navigating the unique challenges of a dynamic startup environment.
Responsibilities
Manage the entire project lifecycle for Class III medical devices, from initial concept through to commercialization and post-market surveillance.
Lead cross-functional teams, including R&D, Quality, Regulatory Affairs, and Manufacturing, to ensure projects are delivered on time, within scope, and on budget.
Develop and maintain detailed project plans, schedules, and budgets, while proactively identifying and mitigating potential risks.
Oversee the design verification and validation processes, ensuring all activities are meticulously documented and meet regulatory requirements.
Coordinate the creation and submission of regulatory filings, including 510(k) and PMA applications, in collaboration with the regulatory team.
Manage supplier relationships and external partners, ensuring they meet project requirements and quality standards.
Facilitate effective communication among all stakeholders, providing regular updates on project status and key milestones.
Support the development and maintenance of quality system procedures related to project management. Qualifications
Bachelor's degree in engineering, life sciences, or a related field.
Minimum of
5 years of project management experience
in the medical device industry.
Demonstrated experience managing projects through
design verification (DV) .
Proven experience with
510(k) and/or PMA submissions .
Experience with
catheter-based products
is highly preferred.
Strong understanding of
FDA regulations
and
ISO 13485 .
Experience with
supplier relations and management .
Excellent leadership, communication, and organizational skills.
Project Management Professional (PMP) certification is a plus.