
Manager, Regulatory Affairs
Are you looking for a dynamic and rewarding career in the healthcare industry? Quest Diagnostics, a leading provider of diagnostic testing, information, and services, is seeking a highly motivated and experienced Manager of Regulatory Affairs to join our team. As the Manager, you will play a crucial role in ensuring that our company complies with all regulations and standards set by government agencies and industry bodies. This is an exciting opportunity to utilize your skills and expertise while making a meaningful impact on the lives of patients. If you have a strong background in regulatory affairs and a passion for healthcare, we want to hear from you!
- Develop and implement strategies to ensure compliance with all regulatory requirements and standards set by government agencies and industry bodies.
- Stay up-to-date on changes and updates in regulations and standards related to the healthcare industry.
- Conduct regular audits and assessments to identify any areas of non-compliance and develop corrective action plans.
- Collaborate with cross-functional teams to ensure that all processes and procedures are in line with regulatory requirements.
- Serve as the primary point of contact for regulatory agencies and manage all communications and submissions.
- Train and educate staff on regulatory compliance and ensure that all employees are aware of their responsibilities.
- Conduct internal reviews and quality assurance checks to ensure compliance with company policies and procedures.
- Develop and maintain all necessary documentation and records related to regulatory compliance.
- Participate in industry conferences and events to stay informed about best practices and new developments in regulatory affairs.
- Provide guidance and support to other departments and stakeholders on regulatory matters.
- Lead and manage a team of regulatory affairs professionals, providing mentorship and guidance to ensure their success and development.
- Proactively identify potential compliance issues and risks and develop mitigation strategies.
- Act as a liaison between the company and regulatory agencies, maintaining positive and professional relationships.
- Continuously improve and streamline regulatory processes to increase efficiency and effectiveness.
- Represent the company in meetings and negotiations with regulatory agencies and industry bodies.
- Monitor and report on the company's compliance status and provide recommendations for improvement.
- Ensure that all products and services meet regulatory requirements and are safe for patients to use.
- Act as an ambassador for the company, promoting a culture of compliance and ethical behavior.
- Handle any regulatory inquiries or investigations and work to resolve them in a timely and satisfactory manner.
- Contribute to the overall success of the company by identifying opportunities for improvement and implementing innovative solutions.
Bachelor's Degree In A Relevant Field Such As Biology, Chemistry, Or Healthcare Administration.
Minimum Of 5 Years Of Experience In Regulatory Affairs, Preferably In The Medical Device Or Diagnostics Industry.
Strong Knowledge Of Fda Regulations And Guidelines, As Well As International Regulatory Requirements.
Excellent Communication And Interpersonal Skills, With The Ability To Interact With Cross-Functional Teams And Regulatory Agencies.
Experience With Regulatory Submissions And Approvals, Including 510(K) And Pma Applications.
Quality Assurance
Process Improvement
Strategic Planning
Communication Skills
Project Management
Data Analysis
Team Leadership
Compliance Management
Risk assessment
FDA regulations
Documentation management
Regulatory Guidelines
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Manager, Regulatory Affairs in Secaucus, NJ, USA is $120,000 - $150,000 per year. This salary range can vary depending on factors such as the specific company, years of experience, and education level of the individual.
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Quest Diagnostics is an American clinical laboratory. A Fortune 500 company, Quest operates in the United States, United Kingdom, Mexico, and Brazil. Quest also maintains collaborative agreements with various hospitals and clinics across the globe.

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