About the role
At Vivalyx, a medical technology startup based in Cologne, we're on a mission to save the lives of those suffering from organ failure.
Our innovative approach aims to significantly improve the vitality and availability of donor organs. As we gear up for certification and related studies, we're seeking dedicated team members (m/f/d) to join us starting as soon as possible, for 32-40 hours per week.
We provide the opportunity to work on groundbreaking technology that has a meaningful impact. You'll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program.
Your role
As the Head of Regulatory Affairs, PRRC and Product Management, you will lead the registration and market launch of one of our core products and act as the go-to person for all regulatory matters, both within our team and towards external partners. This role is based within commuting distance (max. 1.5 hours) of Cologne.
Your responsibilities
Lead the registration and market launch of a core product
Act as the primary point of contact for regulatory matters, internally and with external partners
Craft and implement regulatory strategies, from strategic planning to preparing technical documentation
Collaborate closely with the internal team and external partners on regulatory deliverables
Take a hands-on role in writing regulatory documents given the small team size.
Manage negotiations with partners and vendors
Ensure operations comply with quality management standards such as ISO 13485 and 21 CFR 820
Qualifications
Passion for working in medical technology development
Strong sense of ownership, drive, independence, and commitment
A technical or scientific degree or equivalent training
Several years of experience in a regulatory position in the medical device sector with broad responsibilities across the regulatory spectrum (i.e., companies with five or less people in regulatory such as startups or SMEs)
Expertise in regulatory affairs, including liaising with regulatory bodies and developing regulatory strategy
Project management experience
Confident acting as the primary point of contact for internal teams and external partners
Experience with ISO 13485, ISO 14971, 21 CFR 820, and MDR
Preferably, knowledge of standards such as IEC 60601 and IEC 62366
Strong technical/regulatory writing skills are important
Hands-on, independent working style suited to a small-team / startup environment
Negotiation skills, with experience managing partner and vendor relationships
Proficiency in Microsoft Office and fluent in English, both written and spoken
Select benefits
Company car
Public transport ticket (Deutschlandticket Job / JobTicket)
Urban Sports Club membership
Flexible, mobile working arrangements and flat hierarchies
Regular opportunities for training and professional development
Employee stock option program
We look forward to hearing from you.
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