Regulatory Affairs Specialist

vor 3 Wochen

Giengen an der Brenz, Baden-Württemberg, Deutschland HARTMANN Vollzeit

At HARTMANN, we're committed to helping healthcare professionals focus on what matters most: making a positive impact on people's lives. We believe in the power of collaboration and innovation to drive meaningful change. As a Specialist Regulatory Affairs Operations and Labelling, you'll play a critical role in ensuring our products meet the highest standards of quality and regulatory compliance.

Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with global regulations and standards.
  • Collaborate with cross-functional teams to ensure accurate and timely labeling and documentation of products.
  • Monitor and improve regulatory product documentation and conformity assessments to ensure compliance.
  • Develop and maintain master files for package inserts, labels, and artwork, ensuring accuracy and compliance.
  • Provide strategic and technical consulting on regulatory issues to internal stakeholders.
  • Evaluate product-related regulatory requirements to ensure compliance.

Qualifications:

  • University degree in science or technical sciences or equivalent qualification.
  • Initial professional experience in the medical device environment or regulatory field.
  • Knowledge and/or experience in medical devices, technical documentation, and regulatory product documentation, conformity assessment, and post-market surveillance.
  • Strong interest in and knowledge of electronic regulatory document control and management systems and associated processes.
  • Open and competent attitude when working with internal partners.
  • IT affinity and proficiency with the MS Office package.
  • Strong communication skills, persuasiveness, and assertiveness.
  • Fluent written and spoken German and English.

Benefits:

  • Flexible working conditions, including flexible working hours and mobile working.
  • International mobile working.
  • Attractive ways of combining work and family life, including childcare subsidy.
  • Days paid leave per year, plus special leave for exceptional life events, vacation pay, and special annual payment according to collective agreement.
  • Company pension plan with attractive employer contribution, including 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, Crossfit, and bouldering halls (EGYM Wellpass).
  • Various health and fitness offers, including skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break, etc.
  • Job bike leasing.
  • Attractive discounts on travel, fashion, and technology via our corporate benefits platform.

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