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Medical Device Quality Expert - Regulatory Affairs - Support Internal & External Audits (f/m/d)

Homeoffice
vor 5 Tagen
Heidenheim
Stellenbeschreibung

About HARTMANN

At HARTMANN, we're all in to help, care, protect, and grow. We support healthcare professionals so they can focus on what really matters: to positively impact people's lives. We realize solutions that make a difference. And with your commitment, you can grow in your job every day. At HARTMANN, we believe in the difference you can make.

Join Our Team

Join our team as Expert Component Qualification (QM/RA) (f/m/d) in DEU-Heidenheim.

As an Expert Component Qualification (QM/RA) (f/m/d) for Procedure Packs, you will play a crucial role in ensuring our products meet regulatory and quality standards across global markets. You will serve as a key interface between development, marketing, and suppliers. If you have a passion for Regulatory and Quality in the medical device field, this role offers you the opportunity to make a tangible impact on patient safety and innovation.

Responsibilities

  • Manage Quality and Regulatory Affairs topics related to components for procedure packs in compliance with internal policies and external regulations
  • Support development and marketing teams regarding component qualification
  • Qualify suppliers and maintain up-to-date component documentation
  • Develop, maintain, and deliver training for internal processes and work instructions
  • Support internal and external audits, CAPAs, vigilance, and recall activities
  • Conduct internal trainings on component qualification issues

Qualifications

  • Completed degree in natural sciences, medicine, or a comparable technical discipline; alternatively, a technical qualification with relevant professional experience
  • Formal training or hands-on experience in Regulatory Affairs is beneficial
  • Solid understanding of Quality and Regulatory Affairs in the medical device or pharmaceutical industry
  • Strong intercultural communication skills
  • Analytical mindset with excellent problem-solving capabilities
  • Proficient in both English and German (written and spoken)

Benefits

  • Flexible working conditions, such as flexible working hours and mobile working
  • International Mobile Working
  • Attractive ways of combining work and family life, e.g. childcare subsidy
  • 30 days paid leave per year, plus special leave for exceptional life events, as well as vacation pay and special annual payment according to collective agreement
  • Company pension plan with attractive employer contribution incl. matching model for deferred compensation
  • Plenty of parking spaces, canteen with café bar, and ongoing offers in the employee shop
  • Access to over 6000 fitness and yoga studios, swimming pools, as well as Crossfit and bouldering halls (EGYM Wellpass)
  • Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break, etc.
  • Attractive discounts on e.g. travel, fashion, and technology via our corporate benefits platform
  • Job Bike Leasing

Additional Information

  • Paid Holidays
  • Pension Plan
  • Remote Model: N
  • Country Code: de