Software Product Compliance Manager - BioTech/SaaS/Cambridge, MA
Motion Recruitment · Boston, MA · 3 wk ago
RemoteRemoteLegal$150k–$170k/yrFull-time
Key Responsibilities
- Lead compliance strategy for software products in regulated biotech environments
- Ensure alignment with applicable regulations (e.g., GxP, FDA, CSV)
- Oversee software validation and compliance documentation processes
- Partner with product and engineering teams to embed compliance into SDLC
- Monitor regulatory updates and assess impact on software products
- Support internal/external audits and remediation efforts
Requirements
- 7+ years in compliance, quality, or regulatory roles within biotech, pharma, or life sciences
- Strong experience with software product compliance (GxP, CSV, FDA guidelines)
- Experience working closely with product and engineering teams
- Knowledge of software development lifecycle in regulated environments
- Strong communication and stakeholder management skills
- Experience with SaaS or digital health products in biotech
- Familiarity with validation tools and documentation systems
- Relevant certifications (e.g., CQA, RAC)
Benefits
- Competitive compensation package
- Comprehensive benefits (medical, dental, vision)
- PTO and retirement plan