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

AbbVie

Eschborn, Germany
Regulatory requirements for mdd, mdr
Manage relationships with competent authorities
Quality system maintenance and improvement
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

Job Summary

  • 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.
  • 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.
  • Recruits, coaches and develops organizational talent and 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.

Matching Summary

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.

Skills & Requirements

Must-have

  • Regulatory requirements for MDD, MDR
  • Manage relationships with Competent Authorities
  • Quality system maintenance and improvement
  • Identify, correct, and prevent compliance issues
  • Support of the quality system

Nice-to-have

  • International company career development
  • Attractive benefits package
  • Challenging position in fast-growing industry
  • Flat hierarchies and appreciative mentality
  • Multi-national environment

Key Requirements

  • University degree in sciences or related discipline
  • 7+ years related work experience
  • Quality management system (QMS) experience
  • Experience with regulatory audits and certification management
  • Proven track record in a leadership role with direct reports
  • Proficient with MS Office
  • Willingness to travel up to 30%

Work Rights

Not specified

Tailored Resume

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