Regulatory Affairs Specialist Jobs in Plymouth, MN
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Senior Regulatory Affairs Specialist - Cardiac Surgery
- Minneapolis, MN (7 miles from Plymouth, MN)
- 10 hours ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 10 hours ago
., blood management, cannulae) Extracorporeal life support Coronary artery bypass grafting (CABG) solutions The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies...
Associate Regulatory Affairs Specialist
- Minneapolis, MN (7 miles from Plymouth, MN)
- 11 hours ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 11 hours ago
The Associate Regulatory Affairs Specialist working under the guidance of more senior regulatory specialists/manager will provide support for Cardiac Surgery products....
Regulatory Affairs Specialist - Cardiac Surgery
- Minneapolis, MN (7 miles from Plymouth, MN)
- 11 hours ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 11 hours ago
Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these...
Senior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN
- 1 day ago
- Plymouth, MN
- 1 day ago
Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL...
- Minneapolis, MN (7 miles from Plymouth, MN)
- 1 day ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 1 day ago
Dorsey & Whitney LLP is seeking an associate with two to five years of environmental, natural resources, compliance, or regulatory law experience to join the Regulatory Affairs Practice Group in...
Sr. Compliance Analyst, Employee Benefits
- Minneapolis, MN (7 miles from Plymouth, MN)
- 1 day ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 1 day ago
We are looking to add a Sr. Compliance Analyst to join our Employee Benefits team in Minneapolis, MN ; Waukee, IA ; Kansas City, MO ; or Dallas, TX. Offering a forward-thinking, innovative, and...
Regulatory Affairs Specialist III
- Maple Grove, MN (8 miles from Plymouth, MN)
- 1 day ago
- Maple Grove, MN (8 miles from Plymouth, MN)
- 1 day ago
We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position (hybrid work mode) supporting our rapidly growing Left Atrial Appendage Closure (LAAC) device portfolio...
Aerospace and Defense Regulatory Affairs Specialist
- Maplewood, MN (19 miles from Plymouth, MN)
- 3 days ago
- Maplewood, MN (19 miles from Plymouth, MN)
- 3 days ago
Job Description: Job Title Aerospace and Defense Regulatory Affairs Specialist Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your...
Senior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN
- 3 days ago
- Plymouth, MN
- 3 days ago
The Opportunity We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in our St. Paul or Plymouth, MN locations....
Principal Regulatory Affairs Specialist
- Maple Grove, MN (8 miles from Plymouth, MN)
- 4 days ago
- Maple Grove, MN (8 miles from Plymouth, MN)
- 4 days ago
About the role: We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Peripheral Interventions Division....
Senior Regulatory Affairs Specialist
- Minneapolis, MN (7 miles from Plymouth, MN)
- 4 days ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 4 days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
International Regulatory Affairs Specialist I - Medical Devices (onsite)
- Plymouth, MN
- 7 days ago
- Plymouth, MN
- 7 days ago
We are currently hiring an International Regulatory Affairs Specialist I to work on-site at our Plymouth, MN location....
Abbott Sr. Business System Compliance Analyst in Plymouth , Minnesota Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing...
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
- New Brighton, MN (12 miles from Plymouth, MN)
- 8 days ago
- New Brighton, MN (12 miles from Plymouth, MN)
- 8 days ago
Support and comply with the company's Quality Management System policies and procedures. Ability to act with an inclusion mindset and model these behaviors for the organization....
Remote WorkRemote IT Quality Assurance and Compliance, Analyst
- Saint Paul, MN (17 miles from Plymouth, MN)
- 9 days ago
- Saint Paul, MN (17 miles from Plymouth, MN)
- 9 days ago
Carrington Remote IT Quality Assurance and Compliance, Analyst in Saint Paul , Minnesota Come join our amazing team and work remote from home! What you'll do: Responsible for the timely and...
Remote WorkDemographic Data for Plymouth, MN
Moving to Plymouth, MN? Find some basic demographic data about Plymouth, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Plymouth, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Plymouth, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 9001
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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