Medical Device Regulatory Affairs Specialist

2 days ago

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

Key Skills and Qualifications

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  • Extensive experience in the medical device industry/consulting provides a solid foundation for regulatory consulting services.
  • Expert-level knowledge of product registration strategies enables effective classification and solutions for market entry.
  • Critical review and analysis of product documentation and regulatory submissions require a deep understanding of medical device regulations.
  • Premarket submissions, including FDA 510(k) / de novo, Canadian MDL, EU, Australia TGA, Technical Documentation Files, and global registrations, demand a high level of expertise.
  • Pre-Submission meetings and liaisons with government authorities on behalf of clients require strong communication and negotiation skills.
  • Addressing and responding to deficiencies in product submissions identified by regulatory authorities necessitate attention to detail and analytical skills.
  • Guidance in global Medical Device and In Vitro Diagnostic (IVD) regulations is essential for informed decision-making.
  • Clinical Evaluation / Performance Evaluation Plans & Reports require a thorough understanding of regulatory requirements.
  • Supporting novel devices/technology, including FDA Breakthrough Device Designation / de novo submissions; Health Canada guidance communications; and other international markets, demands adaptability and creativity.
  • Specialized support in areas such as SaMD, cybersecurity, risk management, sterilization, etc., requires a broad range of knowledge and skills.

Quality Management Systems (QMS)

  • Perform assessments and audits for compliance with FDA QSR, ISO 13485, MDSAP, EU MDR, IVDD/IVDR, and other country-specific regulations worldwide.
  • Develop and deliver training modules on quality and regulatory-related topics to enhance client understanding and compliance.
  • Provide additional Quality Consulting services, including internal / supplier audits, gap analysis and remediation, maintenance and updating of client compliance, review and assessment during acquisition due diligence activities, and peer reviews of colleagues' work output.
  • Customize consulting solutions to meet clients' specific needs, both on-site and off-site, and perform Lead Consultant role in multi-faceted projects.
  • Effectively manage workflow to meet business goals and objectives, provide regular reports to management, and coordinate with other offices on global service requests.

Job Description

As a Regulatory Affairs Specialist, you will be responsible for providing expert-level regulatory consulting services to clients. This includes developing effective product registration strategies, performing critical reviews and analyses of product documentation and regulatory submissions, and preparing premarket submissions for various regulatory authorities.

Additionally, you will be responsible for conducting internal / supplier audits, gap analysis and remediation, and maintaining and updating client compliance with regulatory requirements. You will also provide guidance in global Medical Device and In Vitro Diagnostic (IVD) regulations and develop Clinical Evaluation / Performance Evaluation Plans & Reports.

Other key responsibilities include supporting novel devices/technology, providing specialized support in areas such as SaMD, cybersecurity, risk management, sterilization, etc., and participating in the development and maintenance of internal procedures and QMS. Finally, you will be responsible for responding to internal requests for advice and guiding others as an SME.

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