Compliance Specialist Jobs in Minnesota
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.
Preferred Qualifications Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred....
Additional Location(s): US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, well give you the opportunity to harness...
Additional Location(s): US-MN-Maple Grove; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Minnetonka Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At...
Regulatory Operations Compliance Manager Medical Devices (on-site)
- Maple Grove, MN
- 28 days ago
- Maple Grove, MN
- 28 days ago
Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Regulatory Affairs Specialist II Electrophysiology (on-site)
- Plymouth, MN
- 30+ days ago
- Plymouth, MN
- 30+ days ago
Preferred Qualifications Bachelors degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields. Masters degree in Regulatory Affairs....
Principal Regulatory Affairs Specialist - Electrophysiology (on-site)
- Saint Paul, MN
- 45+ days ago
- Saint Paul, MN
- 45+ days ago
Chemistry, life Sciences, Biology (or equivalent vocational qualifications) Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices....
Principal Regulatory Affairs Specialist Electrophysiology (on-site)
- Plymouth, MN
- 45+ days ago
- Plymouth, MN
- 45+ days ago
Chemistry, life Sciences, Biology (or equivalent vocational qualifications) Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices....
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Compliance Specialists in Minnesota offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance Specialist position
- English
- Driving
- Filing
- Quality Systems
- ISO Certified
- Implementation
- Change Control
- ISO 13485
- Quality Management Systems
- Internal Audits
- GxP
- TrackWise
- 21 CFR 820
- ICH GCP
- Institutional Review Board
- Good Clinical Practice
- ICH Guidelines
- Medical Affairs
- Cell Culture
- Scientific Research
- Biology
- Biochemistry
- Drug Development
- Microbiology
- Environmental Monitoring
- Biomedical Engineering
- Stem Cells
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Animal Care
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Education Experience
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Policy Development
- Bachelor's Degree
- Regulations
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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