Compliance Specialist Jobs in Boston, MA
A Compliance Specialist in the biotechnology industry is responsible for ensuring that all operations, policies, and procedures adhere to relevant legal and regulatory standards. They perform regular audits, develop and implement compliance programs, review and update internal policies, and identify any potential areas of compliance vulnerability and risk. Their role is crucial in maintaining the company's integrity and protecting it from any legal issues that could arise from non-compliance. In addition, they are responsible for training and educating staff about compliance requirements and procedures.
Key skills for a Compliance Specialist include a strong knowledge of industry regulations and guidelines, excellent attention to detail, problem-solving abilities, and strong communication and organizational skills. They should ideally have a bachelor's degree in life sciences, biotechnology or a related field. Certifications such as Certified in Healthcare Compliance (CHC) or Certified Regulatory Compliance Manager (CRCM) can be advantageous. Prior to becoming a Compliance Specialist, a professional might have roles such as Compliance Analyst, Quality Assurance Associate, or Regulatory Affairs Coordinator, which provide foundational knowledge and experience in regulatory compliance and quality assurance.
- Waltham, MA (10 miles from Boston, MA)
- 6 days ago
- Waltham, MA (10 miles from Boston, MA)
- 6 days ago
SHE Compliance Manager Introduction to role Are you ready to take on a pivotal role in ensuring safety, health, and environmental compliance? As a SHE Compliance Manager, you'll be at the...
Compliance Manager, Conflicts of Interest, Life Sciences
- Boston, MA
- 7 days ago
- Boston, MA
- 7 days ago
You are someone who thrives in a high-performance environment, bringing a growth mindset and entrepreneurial spirit to tackle meaningful challenges that have a real impact. In return for your...
Compliance Specialist, Conflicts of Interest, Life Sciences
- Boston, MA
- 9 days ago
- Boston, MA
- 9 days ago
You are someone who thrives in a high-performance environment, bringing a growth mindset and entrepreneurial spirit to tackle meaningful challenges that have a real impact. In return for your...
Deliverables expected: Regulatory Compliance Ensure all clinical trials meet FDA, EMA, and ICH standards....
Remote Work- Waltham, MA (10 miles from Boston, MA)
- 18 days ago
- Waltham, MA (10 miles from Boston, MA)
- 18 days ago
Job Description We are seeking a Quality Assurance Associate to support on-the-floor QA issues within the manufacturing suite. This role requires mitigating gaps and risks for all quality and GMP...
Senior Quality Assurance Associate
- Cambridge, MA (3 miles from Boston, MA)
- 20 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 20 days ago
Senior Quality Assurance Associate Alnylam Pharmaceuticals United States, Massachusetts, Cambridge 675 West Kendall Street (Show on map) Jun 09, 2025 Overview The Senior Associate, Quality...
Regulatory & Quality Compliance Manager (m/f/d)
- Waltham, MA (10 miles from Boston, MA)
- 21 days ago
- Waltham, MA (10 miles from Boston, MA)
- 21 days ago
The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as regulatory expert development and new...
Do you have a strong understanding of Sarbanes-Oxley (SOX) Compliance, including financial controls and IT general controls? Have you previously worked at Nasdaq-listed companies? If this sounds...
Regulatory Affairs Specialist II
- Bedford, MA (14 miles from Boston, MA)
- 26 days ago
- Bedford, MA (14 miles from Boston, MA)
- 26 days ago
Regulatory Affairs Specialist II 3.1 3.1 out of 5 stars 180 Hartwell Road, Bedford, MA 01730 Overview: Position Summary: Responsible for domestic and/or international registration and renewal...
Senior Regulatory Affairs Specialist
- Canton, MA (12 miles from Boston, MA)
- 26 days ago
- Canton, MA (12 miles from Boston, MA)
- 26 days ago
About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity...
RWD Compliance Manager Company: Norstella Location: Remote, United States Date Posted: May 23, 2025 Employment Type: Full Time Job ID: R-1204 **Description** **About Norstella:** At Norstella, our...
Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)
- Cambridge, MA (3 miles from Boston, MA)
- 60+ days ago
- Cambridge, MA (3 miles from Boston, MA)
- 60+ days ago
Basic laboratory skills, including working with mammalian cell culture Experience working in an ISO 7 cleanroom environment....
Trials, etc., Advanced technical knowledge in global regulations and industry standards as they apply to clinical research, medical devices and pharmaceuticals and in the conduct of clinical study...
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Microsystems, one of Danaher's 15+ operating...
Clinical Trial Regulatory Affairs Specialist (Boston, MA)
- Boston, MA
- 90+ days ago
- Boston, MA
- 90+ days ago
Knowledge: Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and ethical standards....
Demographic Data for Boston, MA
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Compliance Specialists in Boston, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance Specialist position
- English
- Driving
- Environmental Compliance
- Quality Systems
- ISO Certified
- Geology
- Implementation
- Air Quality
- Document Control
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Drug Development
- Biology
- Environmental Monitoring
- Microbiology
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Data Science
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Auditing
- Investigation
- Written Communication
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Sales
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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