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

JOB DESCRIPTION:

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.

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:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable