Are you a regulatory expert with a passion for ensuring compliance in the dynamic world of medical devices? Our client, a leading Medical Device Firm based in San Francisco, CA, is searching for a seasoned Regulatory Affairs Manager to join their team and drive regulatory strategies that align with industry standards and regulations.
About Our Client:
This forward-thinking medical device firm is at the forefront of technological innovation, dedicated to developing cutting-edge products that enhance patient care. With a strong commitment to quality, safety, and regulatory compliance, they are setting new benchmarks in the medical device industry. They are now seeking a Regulatory Affairs Manager to join their team and ensure compliance with global regulatory requirements.
Responsibilities of Medical Device Regulatory Affairs Manager:
As the Regulatory Affairs Manager, you will play a critical role in:
- Regulatory Strategy: Developing and implementing comprehensive regulatory strategies to ensure compliance with FDA, EU MDR, and other global regulations.
- Submission Management: Preparing, submitting, and managing regulatory filings, including 510(k), PMA, and CE mark submissions.
- Cross-functional Collaboration: Working closely with R&D, quality, and clinical teams to ensure products meet regulatory requirements and gain market approval.
- Compliance Oversight: Monitoring regulatory changes and ensuring the company’s practices and products remain compliant with evolving standards.
- Audit Preparation: Leading regulatory audits and inspections, ensuring readiness and successful outcomes.
- Documentation: Overseeing the maintenance of regulatory documentation, including technical files and product dossiers.
Qualifications:
To excel in the role of Medical Device Regulatory Affairs Manager, you should have:
- Experience: Proven experience in regulatory affairs within the medical device industry, with a solid understanding of global regulatory requirements.
- Regulatory Expertise: Expertise in FDA, EU MDR, and ISO standards, with experience in preparing submissions and managing regulatory approvals.
- Leadership: Strong leadership and communication skills to collaborate effectively with internal teams and regulatory authorities.
- Problem-Solving Skills: A detail-oriented mindset with the ability to navigate complex regulatory challenges and develop solutions.
- Educational Background: A bachelor’s degree in a related field such as Regulatory Affairs, Life Sciences, or Engineering; certifications such as RAC are a plus.
How to Apply:
If you’re a regulatory expert looking to make a significant impact as a Medical Device Regulatory Affairs Manager, we encourage you to submit your resume and a cover letter detailing your qualifications and vision for the role.
Ready to advance your career in regulatory affairs? Connect with us, the best Medical Device Recruiters, and explore our current job opportunities to join a leading medical device firm shaping the future of healthcare!
