Job Title: Project Manager (Medical Device / Biotech Product Development)
Overview:
We are seeking a highly organized and proactive Project Manager with experience managing projects in the medical device, biotechnology, or life sciences industries. This role will focus on lifecycle management, sustaining engineering, and regulatory-driven documentation within a regulated environment (FDA, IVDR). The ideal candidate will have a strong technical background in engineering or life sciences and a proven track record of managing product development projects through design controls processes.
Key Responsibilities:
- Manage projects focused on sustaining engineering and lifecycle management of existing products, ensuring compliance with regulatory requirements (FDA, IVDR).
- Drive the preparation and collection of documentation deliverables (SOPs, protocols, reports) required for design controls and regulatory submissions.
- Lead cross-functional teams through the design control process to ensure products meet regulatory, safety, and quality standards.
- Act as a liaison between engineering, quality, and regulatory teams to ensure project goals and deliverables are met on time.
- Collaborate with internal stakeholders and external partners as needed to advance projects from concept through completion.
- Work closely with teams to understand and align on technical project objectives and requirements, particularly within DNA, RNA, and molecular biology domains.
- Manage project timelines, resources, and deliverables without a focus on budget or IT-related project management.
Must-Have Qualifications:
- Project management experience within R&D, quality, or sustaining engineering in a regulated industry.
- Education or experience in engineering, chemistry, biology, molecular biology, immunology, or biotechnology.
- Hands-on experience with design controls for medical devices or biotech products, including writing SOPs, plans, protocols, and documentation review.
- Direct involvement in product development projects, particularly in early-stage R&D environments (not manufacturing-focused).
- Familiarity working within regulated environments such as medical devices (preferred), biotech, or pharma.
Nice-to-Have Qualifications:
- Experience working with global teams or third-party collaborators.
- Familiarity with IVDR regulations and associated documentation requirements.
