EUROIMMUN US, a subsidiary of PerkinElmer, is an MDSAP registered, ISO 13485:2016, 21 CFR 820 compliant medical device company that develops, manufactures, distributes, and performs service and installation activities of in vitro diagnostic test kits, instruments and software used in the detection of autoimmune status, allergies, infectious diseases and antigen detection.

As we continue to grow, we are seeking a Regulatory Affairs Specialist to support our national Regulatory Affairs department as well as our Central Regulatory Affairs team in our headquarters in Germany. The Regulatory Affairs Specialist supports the planning and execution of regulatory activities for the registration of the assigned product portfolio. This position is actively supporting the product teams to make the products and related documentation compliant to the national and international requirements. The Regulatory Affairs Specialist serves as a subject matter expert for creation of regulatory reports and regulatory requirements. He/she will drive results through being a well-organized team player with a focused and disciplined approach to achieve the joint goals.

The work can be office based or remote and is based on collaboration with our headquarters in Germany and our national subsidiary in the US.

Key responsibilities:

• You actively support all pre-market and post-market regulatory activities of the assigned product portfolio
• You keep track of the national and international requirements for product registrations
• You work with the product teams to ensure the products and related documentation are compliant with the regulatory requirements
• You support with national US registration and the regulatory transformation for compliance to the new EU IVD Regulation 2017/746.
• You create registration dossiers used for registration at international authorities.
• You are a team player who works proactively to achieve our joint goals
• You collaborate cross-functionally and lead regulatory efforts to comply with new regulations (e.g. IVDR) and other requirements including changes to international standards.
• You hold a university degree (e.g. Engineering, Natural Sciences, IT, etc.) with further education in Regulatory Affairs
• You are experienced in Regulatory Submissions and Project Support
• Your proficiency in English and preferably also in German helps you to create the documents for international authorities and communicate effectively with your colleagues
• Knowledge in MS Office tools required

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.

Basic Qualifications:

• Bachelor of Science in a life sciences discipline.
• Minimum of 2 years regulatory work experience in a medical device or pharmaceutical company

Preferred Qualifications:

• Master's degree and further education in Regulatory Affairs preferred.
• Experience with in vitro diagnostic device.
• Experience in FDA 510k, PMA and BLA submissions & CE declarations.
• Knowledge of regulations and standards (CFR, GCP, ICH, ISO, QSR, etc.) affecting IVDs.
• Ability to deal with ambiguous situations, perform work effectively with a high degree of independent judgment without direct oversight with multi-level teams, manage and support multiple projects and resources in a fast paced and changing environment.
• Maintain knowledge of the medical, biological and technical / analytical aspects relevant to the products.
• Demonstrated and effective interpersonal, communication and negotiation skills
• Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates.