Regulatory Compliance Leadership Position

2 weeks ago

Melbourne, Victoria, Australia beBeeCompliance Full time $180,000 - $270,000

Job Title:

Compliance Management Director

Lead a team to ensure regulatory compliance and quality management systems in the medical devices industry.

Key Responsibilities:

  • Develop and implement compliance strategies to meet international regulations and standards.
  • Manage the product registration process for local and international regions.
  • Collaborate with cross-functional teams to ensure awareness of applicable regulatory requirements.
  • Ensure effective documentation of processes to meet compliance requirements.
  • Monitor and review activities related to regulatory bodies and industry trends.
  • Prepare regular reports on product registrations and renewals for key regions.

Required Skills and Qualifications:

  • Strong leadership and communication skills.
  • Excellent analytical and problem-solving skills.
  • Depth of knowledge of medical device regulatory requirements at both the local and international level.
  • Experience in QA and/or Regulatory Affairs management.
  • Ability to work collaboratively with internal and external stakeholders.

Personal Qualities:

  • Resourcefulness in identifying solutions to product registration and regulatory challenges.
  • Customer focus and ability to build strong working relationships.

Work Environment:

  • 5-day working week.
  • Local, interstate, and international travel as required.
  • Located at Bayswater.

Education:

  • Degree or Masters of Bachelor of Sciences or Chemical Engineering.

Essential Skills, Knowledge, and Attributes:

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