Regulatory Affairs Specialist mfd

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving complex analytical challenges increasing productivity in their laboratories improving patient health through diagnostics or the development and manufacture of lifechanging therapies we are here to support them. Our global team of more than 100000 colleagues delivers an unrivaled combination of innovative technologies purchasing convenience and pharmaceutical services through our industryleading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services Patheon and PPD.

Location/Division Specific Information:

Phadia is the leading supplier of fully automatic blood analysis systems for allergy and autoimmune diseases. With our innovative products we set standards worldwide and assist clinicians in providing fast and reliable diagnoses thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific a global company that develops manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.

A Day in the Life:

• Actively participate in product registration projects on defined global markets
• Compile and submit required documentation to obtain import licenses
• Communicate with internal and external partners and with regulatory authorities in specified countries
• Participate in product development as regulatory expert
• Participate in the vigilance process
• Proactively provide regulatory requirements and communicate clear regulatory strategies
• Review and approve product documentation
• Contribute to improved routines and processes within the Global Regulatory Affairs team

Keys to Success:

• A University degree in life pharmaceutical or technical science knowledge in Immunology is of advantage
• Experience in regulatory environment is a requirement
• Practical experience of quality managed systems (esp. ISO 13485 is a requirement
• Fluent in English and German both spoken and written
• Wellstructured analytical approach of tasks
• Excellent team working and communication skills
• Positive attitude and serviceoriented mindset
• Skilled to work across departments in a matrix organization
• Ability of working independently taking responsibility for the management of processes projects and timelines

What we offer:

• Employment with an innovative futureoriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity intensity involvement and innovation

If you are interested please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific each one of our 100000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin disability or any other legally protected status.

Apply today!

Agency notice!

Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.