Regulatory Affairs Strategist

2 weeks ago

Melbourne Sydney, Australia beBeeSpecialist Full time $120,000 - $180,000

Regulatory Affairs Professionals drive the success of our company by developing and implementing regulatory strategies for product development and commercialization.

  • Manage conformity planning for medical devices, including MDR and UKCA conformity.
  • Provide proactive regulatory guidance to cross-functional teams throughout the product lifecycle.
  • Oversee technical documentation, including UK/EU technical files and compilation.
  • Manage post-market activities, such as PMS and PMCF.
  • Ensure quality by driving continuous improvement and maintenance of our Quality Management System.
  • Navigate emerging tech regulations, including the EU AI Act.
  • Act as a key liaison with Notified Bodies, Competent Authorities, and external regulatory consultants.

We seek experienced Regulatory Affairs Specialists with 3-5 years of experience in regulatory affairs within the UK and EU markets. You should have a strong knowledge of EU MDR 2017/745 and UKCA marking requirements. Experience with technical documentation and PMS/PMCF activities is also essential.

The ideal candidate will be a proactive problem-solver with excellent communication and collaboration skills. A Bachelor's degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline is required. Fluency in English is necessary, and proficiency in another European language is beneficial.

Key Responsibilities
  • Develop strategic plans to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to drive product development and commercialization.
  • Communicate complex information to stakeholders.
  • Ensure quality management systems are up-to-date.
  • Monitor and adapt to changes in regulatory environments.

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