Senior Regulatory Affairs Professional

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $180,000
**Senior Regulatory Affairs Specialist Position Summary**This role is focused on ensuring the quality and compliance of our medical device submissions. You will have a key impact in shaping our regulatory strategy, working closely with cross-functional teams to deliver high-quality submissions that meet global regulations.We are seeking an experienced Senior Regulatory Affairs Specialist who can demonstrate their expertise in authoring and reviewing submissions, guiding change assessments, and mentoring team members. This is a critical role within our organization, and we need someone who can drive excellence in regulatory affairs.The ideal candidate will have a strong understanding of global regulations, including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers. They will be able to interpret device-specific requirements and translate them into clear, well-supported regulatory documentation.Key Responsibilities:
  • Author and Review Global Regulatory Submissions: Create and review submissions for various regulatory agencies, including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers.
  • Interpret Device-Specific Requirements: Understand and interpret device-specific requirements and translate them into clear, well-supported regulatory documentation.
  • Lead Regulatory Assessments: Perform significance evaluations and prepare documentation updates for design and process changes.
Product Change & Lifecycle Support:
  • Provide Regulatory Input: Provide regulatory input on system-level verification, biocompatibility, human factors, and labelling updates for high-volume products.
  • Collaborate with Engineering and Quality: Collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance.
Cross-Functional Integration & Design Control Support:
  • Represent RA in Cross-Functional Teams: Represent RA in cross-functional design teams for products under Sydney legal manufacturer scope.
  • Engage Early in Project Scoping: Engage early in project scoping and risk management activities to shape regulatory deliverables and timelines.
Mentorship & Peer Enablement:
  • Mentor Junior Team Members: Mentor junior team members in regulatory interpretation, submission content quality, and cross-functional collaboration.
  • Support Onboarding and Documentation Standardization: Support onboarding and documentation standardization across the team.

The ideal candidate will have a Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline, with 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices).

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