We are looking for a Regulatory Affairs Manager III, working in the Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States.
Manages the planning, conduct and reporting of R&D audits to assure adherence to corporate and R&D policies and procedures, company internal standards, and compliance with regulatory requirements and guidelines.
Manages the planning, conduct, approval, and close-out of audits performed by contract auditors.
Plans audits with vendor auditor.
Facilitates pre-audit activities to ensure audit scope is adequate.
Authors Individual Audit Plans.
We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
4 + years pharmaceutical or biotechnology drug development experience.
4+ years GCP and/or QA or Compliance experience and/or 4+ years of audit or audit management experience.
Excellent communication skills, both verbal and written.
Excellent project management skills.
Able to work independently in a cross-functional, multi-cultural team.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.