Job Description
Job DescriptionProject Manager / QMS Specialist – Medical Device & Combination ProductsQualifications & Skills
- Education:
- B.S. degree in Engineering, a Technical Field, or a related scientific discipline.
- Industry Experience:
- 12+ years of experience in the Pharmaceutical or Medical Device industry
- 5–6+ years specifically supporting medical devices or combination products
- Demonstrated success in drug/device development, lifecycle management, and commercialization
- Regulatory Expertise:
- Deep working knowledge of:
- EU MDR
- FDA 21 CFR Parts 210, 211, and 820 (including 820.30 Design Controls)
- ISO 13485 Quality Management Systems
- Project Management:
- Strong command of project management methodologies, tools, and best practices
- PMP certification highly preferred and considered a strong asset
- Leadership & Communication:
- Exceptional professional presence with the ability to influence and collaborate at all organizational levels
- Proven ability to operate independently with minimal supervision
Position Overview
This is a high‑impact, dual‑focus contract role requiring deep experience in the Medical Device and Combination Product industry. The position operates at the intersection of program execution and quality system compliance, serving as both:
- Project Manager – driving complex development program timelines, cross‑functional alignment, and milestone delivery
- Quality Management System (QMS) Specialist – ensuring adherence to Roche Quality Systems, regulatory expectations, and audit readiness
This role is critical to the successful execution of complex device and combination product programs by integrating disciplined project management with strong quality oversight. The position spans end‑to‑end project planning, governance navigation, documentation management, and continuous improvement of QMS‑related processes.
The Opportunity
You will lead complex projects across the device development lifecycle—from early design through post‑approval—while supporting regional business and compliance activities within Device Development – Business Operations & Compliance Support. Success requires a unique blend of independent project leadership, cross‑functional influence, and the ability to operate effectively within a matrixed organization.
Core ResponsibilitiesProject Management & Execution
- Strategic Planning: Translate device strategy into actionable, inspection‑ready Design & Development Plans
- End‑to‑End Program Leadership: Manage development pipeline projects, line extensions, technology initiatives, and lifecycle activities
- Team Performance: Foster high‑performing team dynamics; drive decision‑making, issue resolution, and cross‑functional collaboration
- Governance Navigation: Guide teams through business process stage‑gates and support technical advisory or governance committee reviews
- Timeline Ownership: Maintain integrated project schedules, identify critical path risks, and ensure on‑time milestone delivery
Compliance & Quality Management System (QMS) Support
- QMS Implementation: Support implementation, maintenance, and continuous improvement of QMS processes, including metric tracking
- Records & Documentation Management: Maintain Design History Files (DHF) and controlled document repositories to ensure accuracy, completeness, and regulatory compliance
- Audit & Inspection Readiness: Lead preparation for internal audits and Health Authority inspections; oversee timely remediation of findings
- Regulatory Alignment: Ensure program execution aligns with global health authority expectations and internal quality standards
Operations & Continuous Improvement
- Risk Management: Identify project and compliance risks early; develop robust mitigation and contingency plans
- Process Excellence: Drive continuous improvement initiatives, leveraging lessons learned and optimizing PM tools and workflows
- Budget & Resource Planning: Forecast and monitor resource needs, project costs, and budget utilization
- Cross‑Functional Coordination: Serve as a central point of alignment across technical, quality, regulatory, and business teams
Job Type & Location
This is a Contract position based out of South San Francisco, CA.
Pay and Benefits
The pay range for this position is $90.00 - $105.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in South San Francisco,CA.
Application Deadline
This position is anticipated to close on Apr 24, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.