Senior Manager (m/f/d) Regulatory Compliance - EMEA

     

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 

Abbott Medical GmbH in Eschborn is looking for a

Senior Manager (m/f/d) Regulatory Compliance - EMEA

based in Eschborn

WHAT YOU’LL DO 

We are recruiting for a Senior Manager, Regulatory Compliance to join our team in the Eschborn Germany location.  In this role, you will manage the compliance function supporting the Cardiovascular & Neuromodulation business units in the area of EMEA, ensure that processes and staffing are appropriately developed and implemented to maintain the quality system, participate in establishing strategic vision/goals in alignment with site organization and business units, ensure compliance within the organization to all applicable internal requirements and external regulations, and establishes/maintains the quality system for the role responsible in the area with oversight. You will also be responsible for interpreting and recommending modifications to companywide policies and practices, interfacing with outside regulatory agencies, identification, correction and prevention of compliance issues, and support of the quality system.

RESPONSIBILITIES:

• Support all business units of CN – CRM, EP, HF, NMD and SH to comply with regulatory requirements of the MDD, MDR, national legislation in EU countries, Middle East and Africa.
• Successfully manage relationships with Competent Authorities and Notified Bodies.
• Serve as contact of the EC Authorized Representative for Abbott Medical Cardiovascular & Neuromodulation.
• Works with the legal manufacturer to ensure Field Action related material and documents are suitable for EMEA, as well determines plan method and timeline, roll out and reconciliation of FSCA.
• Manages, maintains and improve Regulatory Compliance activities in EMEA.
• Monitors compliance with company policies and procedures for the area responsible.
• Makes decisions regarding work processes or operational plans and schedules to achieve compliance objectives for the business units.
• Recruits, coaches and develops organizational talent.
• Supports inspections of the business unit by outside Regulatory Agencies, or internal audits, including any required responses for the role inherent.
• Leads organization responsible for quality support activities including those activities associated with identification and resolution of key product and process performance issues, often through the CAPA system.

EDUCATION AND EXPERIENCE YOU’LL BRING:

Required

• University degree, graduated in sciences, or related discipline.
• 7+ years of related work experience in a similar role within a regulated industry (i.e. medical device, Pharmaceutical, etc.), including quality management system (QMS) experience, and/or experience with regulatory audits and certification management and applicable Regulations/Directives.
• Proven track record in a leadership role with direct reports.
• Proficient with MS Office (Word, Excel, Outlook).
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization as well with external authorities.
• Willingness to travel up to 30%.

Preferred

• Advanced degree in Engineering, Sciences, or related discipline.
• Medical device experience.
• Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization.

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/abbott-/, on Facebook at www.facebook.com/Abbott and on X @AbbottNews and @AbbottGlobal. 

     

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:

EP Electrophysiology

        

LOCATION:

Germany > Hesse : Helfmann - Park 7

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 25 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable