Manager, Regulatory Affairs

Irvine, CA, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

We are seeking an enthusiastic and experienced Manager, Regulatory Affairs to join our team at Edwards Lifesciences. In this role, you will be responsible for providing regulatory guidance and oversight to all areas of the business, as well as managing the development and maintenance of global regulatory strategies. The ideal candidate for this position should have a solid background in international regulatory affairs, excellent communication and organizational skills, and the ability to think critically and problem solve. If you are passionate about the medical device industry and have the drive to work in a fast-paced environment, then this position may be a great fit for you!

Responsibilities:

Develop and maintain global regulatory strategies that are in compliance with applicable international standards and regulations.
Provide regulatory guidance and oversight to all areas of the business.
Monitor changes in relevant regulatory law and guidance, and advise internal stakeholders on potential impacts of these changes.
Oversee the preparation and submission of regulatory documents, such as premarket notifications, labeling submissions, and technical documentation.
Liaise with regulatory authorities to ensure timely review of documents and submission requirements.
Collaborate with internal teams to ensure product designs are in compliance with international regulations and standards.
Manage the analysis, evaluation, and interpretation of collected data and customers’ feedback.
Ensure safety and efficacy of medical device products through proper reviews and risk analysis.
Prepare and present regulatory reports to upper management.
Maintain up-to-date regulatory knowledge and best practices within the medical device industry.

Where is this job?

This job is located at Irvine, CA, USA

Job Qualifications

Excellent Organizational And Communication Skills
Strong Technical Knowledge And Experience In Regulatory Affairs
Understanding Of Medical Device Regulations
Ability To Develop And Maintain Regulatory Plans
Ability To Review And Approve Product Labeling And Promotional Materials
Proficiency In Preparing And Submitting Regulatory Submissions
Ability To Assess And Respond To Regulatory Agency Inquiries
Understanding Of Global Regulatory Guidelines

Required Skills

Documentation
Project Management
Networking
Planning
Strategy
Coaching
Quality
Negotiation
Leadership
Reporting
Compliance
Analysis
Stakeholder engagement
Regulatory
Risk

Soft Skills

Communication
Leadership
Time management
Interpersonal Skills
creativity
Organization
Critical thinking
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Manager, Regulatory Affairs in Irvine, CA, USA is between $116,000 and $140,000. The salary range can vary depending on the experience and qualifications of the individual in the role, as well as the size and type of the organization.

Additional Information

Edwards Lifesciences is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedNovember 9th, 2023

Apply BeforeMay 10th, 2026

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