Senior Specialist (m/f/d) Regulatory Affairs

JOB DESCRIPTION:

breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

In Germany, Abbott has more than 4,000 employees working in manufacturing, research and development, logistics, manufacturing, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Neustadt am Rübenberge, Wetzlar, Eschborn, Cologne, Jena, Munich and Hamburg.

Working at Abbott

At Abbott, you can do work that matters and help people to live a healthier and full life, grow your career, and learn, be your true self. You will have access to:

• Career development with an international company where you can grow the career you dream of
• 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

The Opportunity

This position works out of our Wiesbaden site - Core Diagnostics - Abbott GmbH.

Your Tasks:

• Evaluate product lifecycle activities, including change management, investigations, CAPAs, and post-market activities, for regulatory impact, determining regulatory strategies from technical decisions.
• Partner closely with Quality, R&D, Manufacturing, Technical Operations, international Affiliates and Third-Party Manufacturers to ensure ongoing compliance with global regulatory requirements and represent Regulatory Affairs on cross-functional teams.
• Act as a regulatory SME during internal and external audits.
• Support site-related compliance activities, including batch verification processes.
• Work with international counterparts, notaries and embassies for legal document procurement.
• Lead or contribute to local and global cross functional team initiatives that strengthen product compliance and business continuity.

Your Qualification:

Degree in Life Sciences, Chemistry, Biochemistry, Biology or a related technical discipline.

Minimum 4 years of experience in the Medical Device or IVD industry, with demonstrated expertise in one or more of the following areas: Quality Assurance

• CAPA and Investigations
• Product Development / R&D
• Manufacturing or Technical Operations
• Regulatory Affairs

Proven ability to assess complex technical issues, make risk-based decisions, and work effectively across functions.

Experience participating in audits, inspections, design changes, product lifecycle management, or quality system processes.

Strong communication and stakeholder management skills in a global environment.

Excellent German and English language skills, written and spoken.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Regulatory Operations

DIVISION: CRLB Core Lab

LOCATION: Germany > Wiesbaden-Delkenheim : G02

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: No

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable