Regulatory Affairs Manager

Gefunden in: beBee S CH - vor 3 Wochen

Le MontsurLausanne, Schweiz RegenLab SA Vollzeit
#slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0 0 10px 0;} #slim p {margin-bottom: 16px;} #slim ul {padding-left: 16px;margin-left: 0;margin-top: 10px;margin-bottom: 10px;} #slim li {padding: 0;} #slim h1, #slim h2, #slim h3 {font-size: 12px;font-weight: normal;} #slim .slim_text a {font-weight: bold;color: #000;text-decoration: underline;} #slim .slim_text a:hover {font-weight: bold;color: #FF7500;text-decoration: underline;} #tjs24_root p {margin: 10px 0;} #tjs24_root ul {padding-left: 16px;margin-left: 0;margin-top: 10px;margin-bottom: 10px;font-size: 12px;} #tjs24_root div + ul {padding-top: 10px;} #slim .external-advert {outline: none;border: none;background: none;color: #0000FF;text-decoration: none;cursor: pointer;} #slim .external-advert:link {color: #0000FF;text-decoration: none;} #slim .external-advert:hover {color: #FF7500;text-decoration: underline;} #slim .external-advert:active {color: #FF7500;text-decoration: underline;} #slim .external-advert:visited {color: #0000FF;text-decoration: none;} #slim .bg-warning.external-advert a:link, #slim .bg-warning.external-advert a:hover, #slim .bg-warning.external-advert a:active, #slim .bg-warning.external-advert a:visited {text-decoration: none;color: #0458AB;} #slim .bg-warning.external-advert {background-color: #FFEEE0;} #slim .slim_content.mobile_content {border: none;padding: 0;overflow: hidden;} #slim .btn-primary a {color: #FFFFFF;} #slim .slim_content.mobile_content .external-iframe-hidden {display: none;height: 0;width: 0;position: absolute;} #content #job ul, #content #job ol {list-style: disc outside none;}

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

  • EMEA Regulatory Affairs Specialist

    Gefunden in: beBee S CH - vor 3 Wochen

    Lausanne, Schweiz LHH Vollzeit

    LHH Recruitment Solutions is a specialized talent recruitment boutique. We provide tailored services to help companies find the best candidates for their staffing needs. With deep industry expertise and a commitment to excellence, LHH RS is a trusted partner in Switzerland for many years.Our client is an international company located in Canton of...

  • Director of Regulatory Affairs

    Gefunden in: Talent CH A C2 - Vor 4 Tagen

    Lausanne, Schweiz jobup Vollzeit

    This role is based in Vaud, Switzerland and the successful candidate is required to be in the Canton of Vaud. In this role, you lead the development and improvement of the regulatory affairs capabilities in Europe, Middle East and Africa.  You provide strategic guidance regarding the impact of regulatory issues on corporate strategy and operations for the...

  • Director of Regulatory Affairs

    vor 2 Wochen

    Lausanne, Schweiz jobup Vollzeit

    This role is based in Vaud, Switzerland and the successful candidate is required to be in the Canton of Vaud. In this role, you lead the development and improvement of the regulatory affairs capabilities in Europe, Middle East and Africa.  You provide strategic guidance regarding the impact of regulatory issues on corporate strategy and operations for the...

  • QA/RA Engineer

    Gefunden in: Talent CH A C2 - Vor 4 Tagen

    Le Mont-sur-Lausanne, Schweiz RegenLab SA Vollzeit

    Company: Regen Lab SA based in Le Mont-sur-Lausanne.Join our dynamic team in at a leading medical device company, where innovation and excellence drive our mission to improve healthcare worldwide. With a dedicated team of professionals, we are committed to developing cutting-edge medical devices that make a positive impact on patients' lives.QA/RA...

  • QA/RA Engineer

    Vor 2 Tagen

    Le Mont-sur-Lausanne, Schweiz RegenLab SA Vollzeit

    Company: Regen Lab SA based in Le Mont-sur-Lausanne.Join our dynamic team in at a leading medical device company, where innovation and excellence drive our mission to improve healthcare worldwide. With a dedicated team of professionals, we are committed to developing cutting-edge medical devices that make a positive impact on patients' lives.QA/RA...

  • QA/RA Engineer

    vor 2 Wochen

    Le Mont-sur-Lausanne, Schweiz RegenLab SA Vollzeit

    Company: Regen Lab SA based in Le Mont-sur-Lausanne.Join our dynamic team in at a leading medical device company, where innovation and excellence drive our mission to improve healthcare worldwide. With a dedicated team of professionals, we are committed to developing cutting-edge medical devices that make a positive impact on patients' lives.QA/RA...

  • QA/RA Engineer

    Gefunden in: beBee S CH - vor 3 Wochen

    Le Mont-sur-Lausanne, Schweiz RegenLab SA Vollzeit

    #slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0...

  • Senior Regulatory Affairs and Quality Assurance Engineer

    Gefunden in: Talent CH A C2 - Vor 4 Tagen

    Lausanne, Schweiz Michael Page Switzerland Vollzeit

    International companyMedical devicesSenior Regulatory Affairs and Quality Assurance EngineerOur client is an international company specialized in medical devices.DescriptionTechnical documentation writing management (for Europe & the US);Involvement in the development and design of the company's medical devices;Risk management, from the early life of each...

  • Senior Regulatory Affairs and Quality Assurance Engineer

    Vor 2 Tagen

    Lausanne, Schweiz Michael Page Switzerland Vollzeit

    International companyMedical devicesSenior Regulatory Affairs and Quality Assurance EngineerOur client is an international company specialized in medical devices.DescriptionTechnical documentation writing management (for Europe & the US);Involvement in the development and design of the company's medical devices;Risk management, from the early life of each...

  • Senior Regulatory Affairs and Quality Assurance Engineer

    Vor 5 Tagen

    Lausanne, Schweiz Michael Page Switzerland Vollzeit

    International companyMedical devicesSenior Regulatory Affairs and Quality Assurance EngineerOur client is an international company specialized in medical devices.DescriptionTechnical documentation writing management (for Europe & the US);Involvement in the development and design of the company's medical devices;Risk management, from the early life of each...

  • Head of Medical Affairs

    Vor 5 Tagen

    Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...

  • Capex Project Manager

    Vor 5 Tagen

    Lausanne, Schweiz Capgemini Engineering Vollzeit

    **About Us**: At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...

  • Capex Project Manager

    Vor 5 Tagen

    Lausanne, Schweiz Capgemini Engineering Vollzeit

    **About Us**: At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...

  • CAPEX Project Manager

    Gefunden in: Talent CH C2 - vor 1 Woche

    Lausanne, Schweiz Capgemini Vollzeit

    About UsAt Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project Manager.Job...

  • CAPEX Project Manager

    Gefunden in: Talent CH C2 - vor 1 Woche

    Lausanne, Schweiz Capgemini Vollzeit

    About Us At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...

  • CAPEX Project Manager

    Gefunden in: beBee S CH - vor 4 Wochen

    Lausanne greater area, Schweiz Capgemini Suisse SA Vollzeit

    About Us At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...

  • CAPEX Project Manager

    Gefunden in: beBee S CH - vor 3 Wochen

    Lausanne greater area, Schweiz Capgemini Suisse SA Vollzeit

    About Us At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced CAPEX Project...

  • Capex pm

    Vor 2 Tagen

    Lausanne, Schweiz CAPGEMINI ENGINEERING Vollzeit

    At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for our next CAPEX PM!CAPEX PMJob...

  • Quality Assurance Manager

    vor 1 Tag

    Lausanne, Schweiz Limula Vollzeit

    Limula SA is a Life Science start-up based in Lausanne, Switzerland. Our company was established with _the mission to help bring the most personalised cancer treatments to the patients in need, at reasonable _cost, wherever they are. To achieve this goal, our multidisciplinary team provides a unique cell processing _solution that enables the production of...

  • Clinical Research Associate 2

    Vor 5 Tagen

    Lausanne, Schweiz Veranex, Inc. Vollzeit

    Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...