Project Manager

Title: Project Manager

Location : Foster City, CA (Onsite)

Duration: 12+ Months

Shift & Timing: Regular Business Hours

Pay Range: $100-102/Hour

Job Description:

• The Device Engineering team at Client is seeking a qualified individual to support drug device combination products throughout the commercial lifecycle. This individual will be responsible for the management of combination product change records.
• Additional responsibilities include post market surveillance reports, risk management file maintenance, and general project management across the combination product portfolio.

Responsibilities:

• Coordinate and manage combination product change control records.
• Initiate, route, and close change records for product and manufacturing process changes.
• Initiate, route, and close change records for the design and development of drug device combination products, including the creation and management of design control documentation.
• Manage implementation of changes at multiple manufacturing sites and change record closures.
• Coordinate post-market surveillance reports and risk management file updates.
• Collate surveillance information into yearly reports.
• Generate annual risk summaries and update risk management files.
• Support complaint investigations and documentation.
• Act as a central hub between cross-functional teams to ensure supply continuity.

Knowledge & Skills

• Exceptional organizational and time management skills.
• Understanding of change controls in a regulated industry.
• Experience with project management.
• Working knowledge of relevant US, EU, and international medical device and pharmaceutical regulations.
• Experience with Veeva Vault.
• Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Education & Experience

• 3–5 years relevant experience in related field and a BS or BA.
• Experience with medical device development and / or pharmaceutical operations (cGMP environment) required.

If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I’d be happy to extend to you if they turn out to be a great fit for my client.

Thank you for your time and for your consideration. I look forward to hearing from you.