Operational Regulatory Expert

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time
Regulatory Operations Specialist

This is an exciting opportunity for a highly skilled and motivated individual to join our international regulatory affairs team.

  • We are seeking a Regulatory Operations Specialist who will play a key role in performing a broad range of regulatory operational activities, including analyses, evaluation, preparation, and management of regulatory intelligence, product releases, documentation, support of internal and external audits, and general support of regulatory activities.

Key Responsibilities:

  • Monitor the medical devices regulatory environment and assess regulatory intelligence to inform decision-making.
  • Review and approve advertising/promotion material to ensure regulatory compliance.
  • Support product releases by assisting with Product Release Authorisation (PRA) submissions and approvals.
  • Collaborate with cross-functional departments to ensure regulatory requirements are met and integrated in the Quality Systems.
  • Participate in internal and external audits, providing regulatory input and follow-up as necessary.

Requirements:

  • Degree qualification in sciences, engineering, or a related discipline.
  • Minimum 3 years' experience in Regulatory Affairs with a working knowledge of medical devices legislation.
  • Excellent communication and strong interpersonal skills.
  • Proactive and resilient self-starter able to thrive in a fast-paced innovative environment.

Benefits:

  • We offer a comprehensive compensation package, including competitive salary, benefits, and opportunities for professional development.
  • Our office provides a relaxed and collaborative work environment, with amenities such as free parking, onsite gym, and barista services.

  • Regulatory Expert

    1 day ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $155,000

    Regulatory Affairs Lead Role SummaryThe Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities, ensuring compliance with relevant regulations and legislation. This role bridges strategic and operational regulatory functions, aligning activities with business outcomes.This position requires a strong regulatory professional...

  • Regulatory Legal Expert

    6 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $180,000 - $250,000

    Job Title: Regulatory Legal ExpertWe are seeking a highly skilled regulatory legal professional to join our team. As a Regulatory Legal Expert, you will play a central role in ensuring compliance with applicable laws and regulations, influencing strategic decision-making, and supporting the business in engaging with regulatory authorities.About the Role:This...

  • Regulatory Compliance Expert

    6 days ago

    Sydney, New South Wales, Australia beBeeTransformation Full time $150,000 - $190,000

    Expert Leadership is required to navigate evolving regulatory requirements in SAP IS-U system transformations. A seasoned Transformation Lead is sought after to oversee updates to the SAP IS-U module, manage complex technology projects, and ensure timely delivery that meets regulatory frameworks.Key Responsibilities:Deliver SAP IS-U system changes aligned...

  • Regulatory Affairs Expert

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Regulatory Affairs LeadAbout the Position:The Regulatory Affairs Lead plays a critical role in driving key regulatory activities, ensuring compliance with relevant regulations and legislation. This individual will bridge strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and...

  • Regulatory Affairs Expert

    2 weeks ago

    Sydney, New South Wales, Australia beBeeregulatory Full time $115,000 - $125,000

    Regulatory Affairs Expert | Rare Disease SpecialistThe role of Regulatory Affairs Expert is pivotal in the development, approval, and lifecycle management of innovative medicines. This global position offers a unique opportunity to take full ownership of regulatory affairs across ANZ.Develop and execute strategic regulatory submission plans to support new...

  • Lead Regulatory Expert

    2 days ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $180,000 - $200,000

    About the Position:This is a challenging and rewarding role that requires an individual with exceptional regulatory expertise to oversee key activities, ensure compliance, and drive business outcomes.As a Regulatory Affairs Lead, you will be responsible for bridging strategic and operational regulatory functions, aligning activities with business goals while...

  • Senior Regulatory Expert

    6 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000

    Key Regulatory ExpertWe are seeking a seasoned expert to manage key regulatory interactions across the division and support the Regulatory Interactions Team in overseeing ASIC and other significant regulatory interactions.About This RoleDeliver on regulatory requests and provide visibility of thematic observations and trends to senior stakeholdersSupport...

  • Regulatory Compliance Expert

    6 days ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $120,000 - $150,000

    Job Opportunity: Regulatory Compliance ExpertWe are seeking an experienced professional to lead our regulatory compliance efforts, leveraging their expertise in risk management and stakeholder engagement.Key Responsibilities:Develop and implement a comprehensive compliance framework and regulatory operations matrixConduct thorough risk assessments and...

  • Regulatory Compliance Expert

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Job Title: Regulatory Compliance ExpertAbout the RoleWe are seeking a skilled Regulatory Compliance Expert to provide strategic direction and guidance on healthcare industry regulatory requirements. This individual will work closely with global regulatory bodies, staying up-to-date with best practices and market trends.Main ResponsibilitiesDevelop and...

  • Regulatory Compliance Expert

    4 days ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $99,140 - $130,435

    Job Description:We are seeking a skilled Regulatory Compliance Expert to join our team. In this role, you will assist in developing and implementing best-in-class compliance procedures and policies within the Oceania region.Key Responsibilities:Review and analyze regulatory requirements, bank rules, and legal documents to ensure compliance.Draft and...