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Quality & Regulatory Affairs Specialist - Capital Equipment (m/w/d)

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Germany

Offer summary

Qualifications:

Experience in Capital Equipment servicing, Knowledge of ISO 13485 and Medical Device Regulation, Advanced IT skills (Excel, PowerPoint, Windchill, SAP), Fluent in German and English, Ability to work independently and in a matrix organization.

Key responsabilities:

Support EMEA Quality and Regulatory Organisation
Establish and improve service processes and procedures
Coordinate maintenance activities, emergency repairs, and installations
Participate in special projects and initiatives
Advise management and collaborate with departments

Zimmer Biomet XLarge https://www.zimmerbiomet.com/

16697 - 16697 Employees

See more Zimmer Biomet offers

Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.

What You Can Expect

As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance.

How You Create Impact

Establish, implement and improve service processes, procedures and best practices
Ensure efficiency and accuracy of service department's administrative processes
Coordinate and administrate scheduled maintenance activities, emergency repairs and equipment installations
Participate in special projects and special duties like (re-)validation of technical systems and procedures
Play a key role in growing revenue and margin from spare parts and service contracts
Participate and join strategic initiatives for the service department that align with overall business objectives
Advise general management and work close together with other departments to support the business

What Makes You Stand Out

You have a proven track record in working within Capital Equipment servicing, ideally in Medical Devices or Pharmaceutical industry.

You have developped the ability to work both independently as well as in a matrix organisation and to collaborate with stakeholders across all organisation.

What Will Make You Successful

Knowledge of ISO 13485 and the Medical Device Regulation desirable
Ability to prepare high quality, clear communication materials to the appropriate audience
Advanced IT skills – Excel, PowerPoint, Windchill, SAP
Fluency in German and in English
Discretion and confidentiality

EOE/M/F/Vet/Disability

2906