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The Senior Regulatory Affairs Specialist is ideal for a regulatory professional ready to take the next step in their career and thrive in a dynamic, fast-paced environment. You will lead regulatory strategies and submissions for innovative medical devices, ensuring compliance with global requirements and supporting successful product approvals.
Reporting to the EVP of CMC, this individual will develop business for drug substance/CMC CDMO activities across the West Coast. Preferably based out of SF or SD, the Director is expected to meet clients and attend conferences/trade shows across respective biopharma hubs.
We are seeking a skilled Senior Project Manager with expertise in labs and life science construction to oversee and manage complex projects in Wilmington, MA. The ideal candidate will lead project teams, ensure timely delivery, and maintain high-quality standards in the business services industry.
The Senior Project Manager will be working in tandem with the Regional Mgr. and General Mgr. of the Indy market to continuously drive growth across Indy, oversee their large scale project pipeline, and help scale operations. The plan for this individual is to quickly move into a Project Executive role overseeing all of Indianapolis.
The role oversees quality systems by leading customer complaint investigations, managing audits, and maintaining compliance with multiple industry standards. It also manages document control, calibration processes, and cross‑functional quality improvements while supporting external quality system interactions.
We are seeking a motivated Development Engineer to join a medical device organization. The ideal candidate will be responsible for developing and implementing engineering solutions to meet our project requirements, with a particular focus on applications related to medical device implants. This role involves designing and optimizing components that meet stringent regulatory standards and supporting innovation in implantable technologies.
This Product Development Engineer leads the design and development of instruments from concept through commercialization, ensuring meeting with industry standards. It involves close collaboration with the medical industry, cross-functional teams, and design engineers to deliver effective solutions.
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