Are you an expert in medical device regulatory compliance with a passion for ensuring products meet the highest safety and quality standards? Join our client, a premier Medical Firm based in San Francisco, CA, as a Medical Device Regulatory Compliance Manager. We are seeking a dedicated leader to oversee regulatory strategies and ensure compliance across all product lines.
About Our Client:
Our client is a trailblazer in the medical device industry, renowned for its innovation and commitment to delivering cutting-edge healthcare solutions. With a focus on patient safety, quality, and regulatory excellence, they are shaping the future of healthcare. As they continue to grow, they are searching for a regulatory expert to join their team and ensure compliance with all relevant industry standards.
Responsibilities of the Medical Device Regulatory Compliance Manager:
As the Medical Device Regulatory Compliance Manager, you will play a critical role in:
- Regulatory Strategy: Developing and implementing regulatory strategies to ensure compliance with FDA, EU MDR, and other global regulations.
- Product Compliance: Overseeing the preparation and submission of regulatory filings, including 510(k)s, PMAs, and CE mark applications.
- Internal Audits: Leading internal audits and ensuring adherence to quality management systems, ISO standards, and Good Manufacturing Practices (GMP).
- Cross-functional Collaboration: Working closely with R&D, quality, and manufacturing teams to ensure compliance is integrated throughout product development and production.
- Regulatory Intelligence: Staying up-to-date with evolving regulatory requirements and advising the company on changes that impact product approval and market access.
Qualifications:
To excel in the role of Medical Device Regulatory Compliance Manager, you should possess:
- Regulatory Expertise: Proven experience in regulatory compliance for medical devices, including FDA, EU MDR, and ISO standards.
- Leadership Skills: Strong leadership and communication skills, with the ability to effectively collaborate across departments.
- Attention to Detail: Meticulous attention to detail and the ability to manage multiple regulatory submissions and audits.
- Problem-Solving: Strong problem-solving skills to navigate complex regulatory challenges and ensure timely approvals.
- Education: A bachelor’s degree in a related field is required; advanced certifications such as RAC (Regulatory Affairs Certification) are highly desirable.
How to Apply:
If you are a regulatory compliance professional ready to lead and make a significant impact on the medical device industry, we encourage you to submit your resume and cover letter detailing your qualifications. Be a part of this premier team shaping the future of healthcare!
Looking for more roles in regulatory leadership? Visit our Expert Medical Device Executive Recruitment page and discover top opportunities today!
