Senior Specialist (m/f/d) Regulatory Affairs

Abbott; Wiesbaden; On-site; EUR 65,000 - 90,000; Full time

Job summary

Abbott's Wiesbaden site is seeking a Regulatory Affairs professional to guide lifecycle activities, ensure regulatory compliance, and support audits across global teams. The role emphasizes collaboration with Quality, R&D, Manufacturing, and international affiliates.

Requirements include a life sciences degree and at least 4 years in Medical Device/IVD with QA CAPA, investigations, and regulatory experience; strong German and English skills are essential.

Qualifications

• Degree in Life Sciences, Chemistry, Biochemistry, Biology or a related technical discipline.
• Minimum 4 years of experience in Medical Device or IVD industry with expertise in QA CAPA & Investigations, Product Development/R&D, Manufacturing/Technical Operations or Regulatory Affairs.
• Excellent German and English, written and spoken.

Responsibilities

• Evaluate product lifecycle activities for regulatory impact and determine regulatory strategies.
• Partner with Quality, R&D, Manufacturing, Technical Operations and international affiliates to ensure regulatory compliance.
• Act as regulatory SME during audits and inspections.

Skills

Regulatory affairs

Cross-functional collaboration

Audits

Stakeholder management

German and English proficiency

Education

Life Sciences / Chemistry / Biochemistry / Biology degree

Job description

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.

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

Abbott is about the power of health.

For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.

With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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