Gra Cmc Combination And Stand Alone Specialist

Viforpharma

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Global regulatory device compliance
Us fda liaison for device matters
Drug-device combination products
** Viforpharma is seeking a Lead, Global Regulatory Affairs Device specialist to oversee regulatory strategies for medical devices, particularly plasmapheresis and drug-device combination products. The role requires extensive experience in regulatory compliance and collaboration with cross-functional teams to ensure successful market access and compliance across global regions. --- **

Job Summary

  • Partner closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements.
  • Ensure worldwide regulatory device compliance and successful market access across all regions, closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Matching Summary

Match Score: 75

** Viforpharma is seeking a Lead, Global Regulatory Affairs Device specialist to oversee regulatory strategies for medical devices, particularly plasmapheresis and drug-device combination products. The role requires extensive experience in regulatory compliance and collaboration with cross-functional teams to ensure successful market access and compliance across global regions. --- **

Skills & Requirements

Must-have

  • global regulatory device compliance
  • US FDA liaison for device matters
  • drug-device combination products
  • standalone drug delivery devices
  • plasmapheresis devices
  • EU MDR, ISO 13485, ISO 14971
  • author and review regulatory documents

Nice-to-have

  • strong cross-functional collaboration
  • innovative regulatory approaches
  • drive alignment with business objectives
  • fostering a culture of accountability
  • global perspective and network thinking

Key Requirements

  • Bachelor's degree in engineering or scientific discipline
  • Over 5 years of progressive experience in regulatory roles
  • Extensive experience in global regulatory device environment
  • In-depth knowledge of global device regulatory requirements
  • Demonstrated ability to generate successful FDA, EU, and international submissions
  • Experienced in managing FDA and notified body interactions
  • Demonstrated leadership in managing and developing teams

Work Rights

Not specified

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