Senior Regulatory Manager (m/f/x)

Full time

FULL_TIME
Temedica GmbH https://temedica.com/en/ Product Management

We are looking for a Senior Regulatory Manager who wants to make a difference.

Your tasks

  • Translate regulatory landscape to product specific action plans (e.g. MDR IIa, FDA 21 CFR 820)
  • Evaluate product specific risk management
  • Contribute all regulatory aspects to technical documentation (jointly with QM)
  • Manage certification process
  • Oversee/ do post-market surveillance

Your profile

  • Minimum bachelor degree in science or engineering
  • > 5 years of regulatory experience in the medical device industry, preferably with medical software
  • Comprehensive regulatory knowledge, e.g. guidelines, policies, applicable product laws/standards
  • Strong project management experience, especially with supporting new product developments and launches
  • Fluency in English and German

Job details

Start date: as soon as possible/ anytime
Workplace: Munich

Are you interested?

Your persons of contact are Kerstin Dannenberg (HR) and Gloria Seibert (CEO)

We’re looking forward to hearing from you!


Benefits at Temedica

At Temedica we are an open and international team with a beautiful office in the heart of Munich. The next beer garden and the famous Oktoberfest are just around the corner ;)

Trust

We believe in you. That's why we give you maximum responsibility and trust from day one.

Feedback

We think it is essential to engage in lively dialog and give feedback based on a culture of fairness.

Goals

We work determinedly toward achieving our goals, and we embody our common values.

 

Team Events

Here you“ll get fantastic coffee, snacks and, of course, a great place to work.

 

Paul-Heyse-Str. 27 Munich 80336 Bayern DE Date Posted: 2019-11-21