Regulatory Affairs Manager

vor 1 Monat

Le MontsurLausanne, Schweiz RegenLab SA Vollzeit

Regen Lab SA based in Le Mont-sur-Lausanne. We are a Swiss leading medical device company comprised of a dynamic team dedicated to revolutionizing healthcare. Our commitment to innovation and excellence drives us to develop cutting-edge medical devices that positively impact patients' lives worldwide.

Regulatory Affairs Manager

Position Overview:

For our site located in Le Mont-sur-Lausanne, we are seeking a highly skilled and motivated Regulatory Affairs Manager to join our team. As the Regulatory Affairs Manager, you will play a pivotal role in ensuring compliance with regulatory requirements and guiding our products through the complex landscape of medical device regulations. You will collaborate closely with cross-functional teams to develop and execute regulatory strategies, ensuring timely approvals and market access for our innovative medical devices.

Responsibilities:

Develop and implement regulatory strategies to ensure compliance with global medical device regulations, including but not limited to FDA, EU MDR, and other international regulations.

Prepare and submit regulatory filings, including 510(k) submissions, PMA applications, CE marking applications, and other regulatory submissions as required.

Serve as the primary point of contact for regulatory agencies and notified bodies, providing timely responses to inquiries and facilitating interactions throughout the regulatory review process.

Review and approve product labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.

Stay abreast of changes in regulations and guidance documents, providing regulatory guidance and training to cross-functional teams as needed.

Collaborate with internal stakeholders, including R&D, Quality Assurance, and Clinical Affairs, to ensure regulatory requirements are incorporated into product development processes.

On site working.

Qualifications:

Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.

Minimum of 5 years of experience in regulatory affairs within the medical device industry, with a proven track record of successful regulatory submissions and approvals.

In-depth knowledge of medical device regulations, including FDA regulations (21 CFR Part 820, 21 CFR Part 807), EU MDR, ISO 13485, and other international regulations.

Experience interacting with regulatory agencies and notified bodies, with a strong understanding of regulatory processes and requirements.

Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeh

Strong analytical and problem-olders.solving skills, with a keen attention to detail and the ability to prioritize and manage multiple projects simultaneously.

 

Why Join Us:

 

Opportunity to make a meaningful impact on patients' lives by contributing to the development and commercialization of innovative medical devices.

Collaborative and supportive work environment where your ideas and contributions are valued.

Professional development opportunities to expand your skills and advance your career in regulatory affairs.

If you are passionate about regulatory affairs and thrive in a fast-paced and dynamic environment, we invite you to join our team and be part of our mission to improve healthcare worldwide. Apply now by submitting your resume and cover letter detailing your qualifications and experience in regulatory affairs. We look forward to hearing from you

 

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