Regulatory Affairs Specialist

vor 4 Wochen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

At PAUL HARTMANN AG, we empower healthcare professionals to concentrate on their essential mission: enhancing the quality of life for individuals. Join our dynamic team as a Regulatory Affairs Specialist and immerse yourself in a diverse and stimulating role within a global framework.

This position offers flexibility, including the option for part-time engagement.



Key Responsibilities:

  • In this multifaceted and international position, you will oversee the timely labeling and deployment of products in compliance with regulatory standards.
  • Conduct global oversight and enhancement of regulatory product documentation and conformity evaluations.
  • Manage the master files for package inserts, labels, and artwork, ensuring accuracy and adherence to necessary labeling criteria throughout the review and approval stages.
  • Propose enhancements to the IT infrastructure for the management of regulatory product documentation.
  • Offer strategic and technical guidance on regulatory matters.
  • Perform final assessments of product-related regulatory obligations.

Qualifications:
  • A university degree in scientific or technical disciplines or an equivalent qualification.
  • Preferably, initial professional experience in the medical device sector or a related regulatory field.
  • Familiarity with medical devices, technical documentation, regulatory product documentation, conformity assessment, and post-market surveillance.
  • A keen interest in and knowledge of electronic regulatory document control and management systems, along with associated processes.
  • A collaborative and competent approach when engaging with internal stakeholders.
  • Proficiency in IT and the MS Office suite.
  • Excellent communication skills, with the ability to persuade and assert effectively.
  • Fluency in both written and spoken German and English.

Benefits:
  • Flexible working arrangements, including adaptable hours and remote work options.
  • International mobile working opportunities.
  • Supportive measures for balancing work and family life, such as childcare subsidies.
  • 30 days of paid leave annually, in addition to special leave for significant life events, vacation pay, and special annual bonuses as per collective agreements.
  • A company pension scheme with attractive employer contributions, including a matching model for deferred compensation.
  • Ample parking, a canteen with a café bar, and ongoing offers in the employee shop.
  • Access to over 6000 fitness and yoga facilities, swimming pools, as well as Crossfit and bouldering centers (EGYM Wellpass).
  • A variety of health and wellness initiatives, including skin cancer screenings, online mental health courses, massage services, and yoga sessions during lunch breaks.
  • Job bike leasing options.
  • Exclusive discounts on travel, fashion, and technology through our corporate benefits platform.

Shape a career that prioritizes healthcare customers, is future-ready, and rooted in a culture of trust and transparency.

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