Clinical Development Manager

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with subsidiaries in China and Thailand, we are pioneering a novel surgical robot for advanced endoscopic surgeries. ISO 13485 certified with international safety accreditations awarded such as the FDA and CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as deep cavity in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which have been strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific's leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust engineering team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Clinical Development Manager to join us on this journey. You will be involved from the early-stage product development process, requiring pivotal end-user inputs all the way to the testing stages of product validation. You shall serve as the crucial link between the company's engineering team and our external key opinions leaders, as well as play a part in managing and extending our partnerships with healthcare Centers of Excellence around the globe. These collaborations will be centered around pre-clinical and clinical evaluations of current and future medical device products in our portfolio.

Your responsibilities shall include the following:

• Understanding the clinical needs from end-users and translate them into technical requirements.
• Providing feedback from end-users and give your insight on the clinical workflow use of the products.
• Designing and running benchtop ex vivo and preclinical feasibility studies.
• Analyzing feasibility study findings and write reports for regulatory documentation filing.
• Assisting in the drafting of risk management documents such as the dFMEA and aFMEA.
• Participating and contributing during project design review meetings.
• Liaising with CROs and hospital partners to plan and perform product clinical studies.
• Assisting in drafting contractual agreements with partners (research collaboration, consultancy, etc.).
• Staying up to date with medical device trends, clinical trials and publications to provide clear-sighted improvements and inputs to our product portfolio, as well as studies planning.
• Overseeing local and international awards and grants submissions.

Your Qualifications & Experience

• Minimum Master's degree in Engineering or Science.
• At least 3 years experience in a clinical or human factor engineering role in the medical device industry.
• Familiar with medical device design control process.
• Understanding of IEC62366, IEC60601-1-6 and USFDA human factor and usability engineering guidance document will be advantageous.
• Excellent communication and interpersonal skills.

Contact

Please send your CV and accompanying cover letter to: . We look forward to receiving your application!