Senior Manager (mfd) Regulatory Compliance EMEA

JOB DESCRIPTION : About Abbott

Abbott is a global health care leader creating breakthrough science to improve peoples health. Were 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 Abbotts German headquarters in Wiesbaden and its sites in Hanover Neustadt am Rübenberge Wetzlar Eschborn Cologne Jena and Hamburg.

W orking 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 r ecognized 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 YOULL DO

We are recruiting for a Senior Manager Regulatory Compliance to join our team in the Eschborn Germany 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 performance issues often through the CAPA system.

EDUCATION AND EXPERIENCE YOULL 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.

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.

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

Required Experience : Senior Manager

Key Skills : Compliance Management,Risk Management,Financial Services,PCI,Banking,Cost Accounting Standards,Quality Systems,Research Experience,NIST Standards,Securities Law,SOX,ISO 27000

Employment Type : Full-Time

Experience : years

Vacancy : 1

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