Regulatory Affiars Manager (m/w)

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Bayern Germany.

Our client is a professional Medical Devices organization, based in Bayern, Germany.
The company is specialized in cardiovascular implants and has over the past years developed a significant marketshare in this segment.

ROLE DESCRIPTION

In order to maintain the high standard we are looking for a Regulatory Affairs Manager who has significant knowledge in international registrations.

RESPONSIBILITIES

- Develop and execute the regulatory affairs strategies and procedures for existing and new products for worldwide product registration including Product Master Files (PMF)
- File and document DIMDI Notifications, Recalls, MDD Vigilance, PSUR Reports and annual reports
- Coordinate with product development including the process validation and verification including Design Control
- Support quality team with Quality and overlapping topics such as risk management, packaging, labelling, CAPA, etc…
- Support with the internal and external audits

REQUIREMENTS

- Minimum a Bachelor’s degree, Masters preferable in Medical Engineering or other Life Science field
- Alternatively have demonstrated relevant experience in the field of regulatory affairs in Medical Devices
- A min. 3-5 years’ experience in regulatory affairs dealing with medical devices class III
- Experience in cardiovascular implants as well as drug devices are advantageous
- Excellent knowledge in the relevant ISO’s including ISO 13485, 14971 and ISO 10993
- Good knowhow in regulatory requirements for the worldwide registration (CE, FDA, APAC)
- Team player with outstanding interpersonal and communication skills and integrative thinking
- Fluent in English and German is a must

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.