Regulatory Affairs Project Manager - Medical Devices (m/f/d)

Lumis International

Regulatory Affairs Project Manager - Medical Devices (m/f/d)

Lumis International

Berlin, Germany

Lumis International GmbH, headquartered in Berlin, is a consulting company for the biopharmaceutical and medical device industry. We act as a legal representative and data representative for our clients conducting clinical trials in Europe, Switzerland and UK.

Additionally, we offer regulatory services that are divided into two branches:

In biopharmaceuticals we support early-stage, innovative companies with their clinical drug development;
For medical devices, we provide full-lifecycle solutions. We support clients with QMS and technical documentation preparation as well as finding suitable notified bodies for CE-marking. Following certification, we can act as their authorised representative and support with post-market surveillance.

For our growing team we are currently recruiting a Regulatory Affairs Project Manager - Medical Devices (m/f/d) to support our regulatory activities at the Lumis International offices in Germany, UK, Spain and Switzerland. The position plays a key role in providing best practice solutions to our medical device clients.

You will report to the Head of Regulatory Services (Lumis International Ltd) and work in close cooperation with the Business development team.

Role Description

This is a full-time remote/hybrid role (part-time possible) for an experienced Regulatory Affairs Project Manager - Medical Devices (RA PM). The successful candidate will serve as Lumis' medical device regulatory subject matter expert, leading project delivery, supporting business growth, enhancing industry visibility, and further developing the Lumis brand as a recognized provider of medical device consulting services.

Main responsibilities:

Developing a business strategy for medical device regulatory services;
Implementing internal SOPs and operational tools, as needed;
Directly liaise with clients to ensure the smooth running of medical device projects;
Deliver medical device regulatory projects as per client expectations;
Contribute to proposal development;
Support sales calls with clients as a Subject Matter Expert;
Act as Person Responsible for Regulatory Compliance (PRRC) for authorised representative service, if possible;
Develop marketing content – prepare blogs, whitepapers, webinars;
Attend conferences and conduct keynote speeches;
Work seamlessly and remotely within the Lumis team.

Qualification

Bachelors Degree in life sciences, engineering, or relevant subject;
4+ years’ experience in medical device quality systems and regulatory affairs, including: CE-marking devices, interacting with notified bodies, auditing, and clinical development;
Experience in working with AI enabled medtech solutions (preferable);
Experience in a regulatory consultancy, client-facing role (preferred);
Outgoing, sociable, confident character;
Attention to detail and strong analytical skills;
Ability to work independently and remotely.

Our offer

Exciting and varied tasks in an international, dynamic and expanding consulting company;
Positive working atmosphere promoting individual freedom and responsibility;
Regular team meeting online and in person;
Competitive salary;
Hybrid working solution.