Senior RA Specialist

Our client is a global healthcare leader improving patients’ lives in over 150 countries, with their business divisions providing leading technology and quality care across all areas of healthcare. They employ over 100,000 talented employees, serving people in over 150 countries.

Through empowering research and striving for quality, they are continuously improving the way people manage their health at all stages of life. Every day, more than 10 million tests are run on their instruments, providing lab results for millions.

The Position
This position supports their Diagnostics Division, providing solutions and test assays addressing some of the world’s greatest healthcare challenges. This position will join the team at the Thuringia site, covering a product portfolio spanning key heath and therapeutic areas, including infections disease, cardiometabolics, informatics and toxicology.

The solutions made at this site will be used in hospitals, laboratories, and clinics around the globe to provide critical information for hundreds of health conditions including heart attacks, blood disorders, infectious diseases and cancers.

Responsbilities

• Prepare technical files and manage execution of submissions to Notified Bodies and Regulatory Authorities.
• Manage execution of submissions in accordance with regulatory plans and timelines.
• Support all other departments and external stakeholders with regulatory issues.
• Support the regulatory department to ensure efficient and compliant business processes and coordinate operating procedures within a cross-functional team.
• Assist with label development and review for compliance before release
• Contribute to process / product improvement projects and risk management

Requirements

• Degree in Biochemistry, Medicine or another related life sciences subject.
• Three years of working experience in Regulatory Affairs role within a Molecular Diagnostics manufacturer, candidates from the MedTech industry will also be considered.
• Expereince writing technical files in accordance to IVDD/IVDR or MDD/MDR.

• Working in an ISO 13485 certified environment, expereince in another highly regulated industry is considered.
• Strong written and verbal communication skills, both in English and German
• Ability to adapt quickly and effectively to shifting priorities

• Very strong attention to detail
• A team player, preferably with an understanding of international business cultures.

What they offer

• Career development with an international company where you can grow and shape your own career.
• An attractive benefits package (e.g., attractive Pension Plan, a company bike, employee stock purchase program)
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• A challenging position in a fast-growing crisis independent industry
• To become part of a dynamic, highly educated, highly skilled, and motivated team
• Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication
• Multi-national environment, where we foster the development of our talents within the enterprise