Specialist Regulatory Affairs (m/f/d)
Job ID: 231129BR

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 life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

As one of the largest biotechnology companies in Germany, we research, develop and produce innovative biomarker diagnostics and distribute our products in more than 65 countries. B•R•A•H•M•S is based in Hennigsdorf near Berlin, which is home to about 285 of the company’s 550 employees worldwide.

Discover Impactful work:
In this position, you will be responsible for the registrations, approvals and conformity assessments of our products in your area of responsibility during the various product life phases in Europe (CE marking according to IVDR (EU) 2017/746) and in global projects (with a focus on China, Japan, USA, Russia, among others).

A day in the life:

• You will compile technical documentation as well as registration dossiers for the products in your area of responsibility and independently manage the registration status of these products in coordination with the marketing organization.
• You are the internal and external contact person for the registration processes in your area of responsibility.
• You see yourself as an internal consultant for the planning and implementation of regulatory requirements in the product life cycle and you are involved in the planning and execution of audits with regard to regulatory requirements.

The keys to success:

• University degree in the field of life science, engineering or technical education (MTA, BTA, PTA) with corresponding further education or professional experience.
• 3 to 5 years of professional experience in the field of regulatory affairs
• Professional experience in the "In-vitro" diagnostics segment with a focus on analyzer and software is desirable
• Solid knowledge of IVDD, GMP, ISO 13485, 21 CFR 820 and technical product standards.
• Proficient in Microsoft Office
• You are an open-minded personality and possess excellent organizational skills, are a strong communicator and enjoy working in a team and with different cultures
• Structured, independent and autonomous working style
• You are solution-oriented with a high level of energy
• Hands-on, very good command of written and spoken English.

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