Specialist (m/f/d) Regulatory Affairs & Quality

Job description

About Abbott

Abbott is a global healthcare leader, creating 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 Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn, Cologne, Jena 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

• An attractive benefits package (e.g. attractive Abbott 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

The Opportunity

This position works out of our Munich location in the Laralab GmbH.

Your Tasks:

• Lead regulatory clearance for new AI products and modules, focused on CE and FDA regulatory pathways for medical device software

• Contribute to key regulatory areas such as technical documentation, clinical evaluation, and safety reports

• Lead risk management activities throughout the product lifecycle in accordance with ISO 14971, including hazard analysis, risk assessments, and risk-benefit evaluations

• Direct communication with responsible regulatory authorities (e.g., Notified Bodies, FDA, BfArM)

• Stay ahead of the fast-paced evolution of global regulatory requirements and AI capabilities to ensure the compliance of our medical device software

• Reporting adverse events/incidents to the relevant regulatory authorities

• Supporting product recalls, safety notices, and field safety communications

• Participating in quality assurance activities (CAPAs, supplier evaluations, internal audit etc.)

• Support the continuous improvement and efficient operation of our Quality Management System in accordance with ISO 13485, EU MDR, and applicable FDA requirements

• Serving as a point of contact for internal business functions regarding inquiries related to Regulatory Compliance and Quality Systems

Ihre Qualifikation:

• Successfully completed degree in a scientific, technical, or medical field (preferably Biomedical Engineering, Medical Technology, Life Sciences, Regulatory Affairs, Software Engineering, Computer Science, or a related scientific or technical discipline)

• Professional experience in Regulatory Compliance, Regulatory Affairs, and/or Quality Management within a medical device company

• Experience with regulatory submissions and approval processes for medical device software (esp. CE and FDA)

• Knowledge of global laws, standards and regulations applicable to medical device software (e.g. MDR 2017/745; 21CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971, IEC 81001-5-1)

• Strong analytical skills, attention to detail, and organizational abilities

• Demonstrated ability to independently own tasks from start to finish proactively removing blockers and following through to completion

• Interest and understanding of AI technology and frameworks are a plus

• Excellent communication skills and a solution-oriented mindset

• Ability to handle sensitive data with a high level of confidentiality and professionalism

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.

We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.

Connect with us at www.abbott.com, on LinkedIn at https://www.linkedin.com/company/abbot

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

Job family Operations Quality

Divisione MD Medical Devices

Sede di lavoro Germany > München : Herzog-Heinrich-Straße 13

Sedi di lavoro ulteriori

Turni Standard

Viaggiare No

Controllo medico Not Applicable

Attività lavorative significative Not Applicable