Product Compliance Manager (m|f|d)

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Sartorius Stedim Biotech GmbH

Product Compliance Manager (m|f|d)

Sartorius Stedim Biotech GmbH
Göttingen or Helsinki
Vor Ort
Feste AnstellungVollzeit

Über Sartorius

We are currently seeking a Product Compliance Manager
m|f|d ) for our Elec. Design & Product Compliance team
based at our headquarters in Goettingen , Germany
(Sartorius Lab Instruments GmbH & Co. KG) or Helsinki,
Finland with the option of remote work. In this position you
will be responsible for ensuring that regulatory strategies and
regulatory activities are effectively executed to meet the
business objectives and legal requirements. You will organize
regulatory information, track and control submissions and
provide guidance and advice to internal stakeholder.

What you will accomplish together with us

  • Manage the activities of Product Compliance within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
  • Provide expert regulatory input to strategic decision making; including review, prioritization, and external communications
  • Support the development and establishment of policies and standards
  • Coordinate successful submissions and approval of applications
  • Plan, undertake and oversee regulatory inspections
  • Liaise and negotiate with regulatory authorities
  • Provide advice about regulations to relevant stakeholder
  • Review and report overall quality status
  • Keep up-to-date with changes in regulatory legislation and guidelines

 

What will convince us

  • Bachelor degree in a science, engineering or related field
  • Several years relevant experience within the Regulatory Affairs discipline
  • Deep knowledge of the relevant Regulatory requirements
  • Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations
  • Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources
  • Proven analytical skill and technical/scientific competence
  • Attention to details and ability to appropriately assess risks
  • Strong initiation and organizational skills
  • Excellent communication skills, with ability to influence others and negotiate successful outcomes
  • Proactive, quick learner and independent worker able to effectively multi-task in a strongly growing organization
  • Team-player, able to positively influence Team members at all levels
  • Fluent in English and willingness to travel international
  • Identification with our core values: Sustainability, Openness, Enjoyment

 

What we offer

Our ambition is to simplify progress in life science research and the biopharmaceutical industry to help translate scientific findings into new therapeutics faster and more efficiently. So that more people can obtain access to better medicine. Nearly 14,000 employees at more than 60 production and sales locations worldwide are committed to this vision. And together, we have grown strongly over the past years. Do you also want to contribute to our vision? Grow with us and benefit from working with a Global Player that has kept its familiar atmosphere:

  • Opportunity to work in a newly created role and drive a new Sales strategy together with a highly motivated team
  • Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths
  • Open and highly collaborative culture: mutual support within teams and working as equals, team spirit and international collaboration
  • Work-life balance: Limited amount of travel and the opportunity to work remotely
  • Ambitious goals: Sartorius plans to double its sales revenue approximately every five years and expects to grow its global team to approximately 15,000 people in 2025.
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Ort
Sartorius Stedim Biotech GmbH
Göttingen or Helsinki