Regulatory Affairs Specialist Jobs in Hazel Park, MI
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.
Procurement & Compliance Analyst
- Oakland County (MI)
- Waterford, MI (20 miles from Hazel Park, MI)
- 4 hours ago
- Waterford, MI (20 miles from Hazel Park, MI)
- 4 hours ago
Overview & Benefits Oakland County is more than just a workplace. It is a place where you can make a real difference. As one of Michigan's leading public service organizations, we are committed to...
In PersonFinancial Aid Compliance Analyst
- Wayne State University
- Detroit, MI (8 miles from Hazel Park, MI)
- 3 days ago
- Detroit, MI (8 miles from Hazel Park, MI)
- 3 days ago
Financial Aid Compliance Analyst Wayne State University is searching for an experienced Financial Aid Compliance Analyst at its Detroit campus location. Wayne State is a premier, public, urban...
In PersonRegulatory Affairs Specialist I
- Getinge Group
- Fraser, MI (9 miles from Hazel Park, MI)
- 20 days ago
- Fraser, MI (9 miles from Hazel Park, MI)
- 20 days ago
Supports with the documentation and activities related to EU MDR, PMA, and 510(k) submissions when required. Communicate with regulatory agencies as needed....
Remote- System One
- Madison Heights, MI (3 miles from Hazel Park, MI)
- 27 days ago
- Madison Heights, MI (3 miles from Hazel Park, MI)
- 27 days ago
Job Title : Regulatory Affairs Specialist Location : Madison Heights, MI Contractor Work Model : Onsite Hours : M F 8am 5pm Compensation : $26.00/hr Type : Contract, Potential for extension or conversion...
In PersonTrade Compliance Analyst (TCA)
- Mindlance
- Troy, MI (10 miles from Hazel Park, MI)
- 45+ days ago
- Troy, MI (10 miles from Hazel Park, MI)
- 45+ days ago
Trade Compliance Analyst (TCA)#26-11210 Troy, MI All On-site Job Description ASAP start date 6 Months On site JOB DESCRIPTION ROLE AND RESPONSIBILITIES Functions as the customer facing contact for...
In PersonRN Clinical Regulatory Compliance Specialist
- Corewell Health
- Dearborn, MI (11 miles from Hazel Park, MI)
- 60+ days ago
- Dearborn, MI (11 miles from Hazel Park, MI)
- 60+ days ago
This is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health Dearborn Hospital. About Corewell Health Our new name...
In Person- Robert Bosch
- Farmington Hills, MI (16 miles from Hazel Park, MI)
- 90+ days ago
- Farmington Hills, MI (16 miles from Hazel Park, MI)
- 90+ days ago
Company Description We Are Bosch. At Bosch, we shape the future by inventing high-quality technologies and services that spark enthusiasm and enrich people's lives. Our areas of activity are every...
In PersonDemographic Data for Hazel Park, MI
Moving to Hazel Park, MI? Find some basic demographic data about Hazel Park, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hazel Park, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hazel Park, MI offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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