Regulatory Affairs Specialist
Are you a dedicated Regulatory Affairs professional looking for a growth opportunity within a dynamic medical technology company?
We're partnering with a highly innovative German manufacturer specialising in respiratory diagnostics to find their next team member.
As a Regulatory Affairs Specialist, you'll be a pivotal bridge between the technical development teams and external registration partners. Your primary focus will be on the structure of technical files and country-specific documentation for international product approvals. This is a fantastic chance to grow your expertise as the company pushes further into global markets beyond Europe.
Role Incentives
* Competitive Salary & Perks
* Permanent Full-Time Role
* Professional Growth
* Supportive Team
Your Key Responsibilities
* Prepare and submit technical documentation for international product approvals.
* Manage and maintain regulatory documentation in collaboration with the Development and Technical Documentation departments.
* Ensure compliance with all relevant regulatory requirements and standards.
* Communicate with international specialist dealers and regulatory authorities.
* Act as a key liaison between the technical development teams and external registration partners, focusing on the structure of technical files and country-specific documentation.
Requirements
* Fluency in English & German (C1 level)
* Completed professional training in a medical device, technical or pharmaceutical field.
* Basic knowledge of regulatory requirements (MDR, FDA, ISO 13485, etc.).
* Strong analytical skills for interpreting regulatory requirements.
* Structured and thorough work ethic.
* Team player in collaborating with various departments and external stakeholders.
Reach out to Alisa Liddell for more information about the company culture, and long-term development plans.
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
* Expert advice on your CV and cover letter
* Guidance on salary expectations
* Personalized interview preparation
* Connections to exclusive job opportunities
* Assistance in negotiating the best possible offers
* 50% of the CVs we send to clients are accepted
* Accepted or declined, either way we will provide you with feedback
We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
If you are interested in this role, please apply with your CV or contact Alisa Liddell for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
alisa.liddell@adaptivelifescience.com
DE Tel: +49 30 16638376