Senior Regulatory Affairs Associate (BBBH35729) North Shore, Australia

Benefits

  • Responsibility for a large portfolio with high class devices
  • Part of a high performing team where the members have tenure in their service to the company
  • Development opportunity to manage
  • Reports to an established manager who is highly supportive and pro-development
  • Flexible, work/life balance

About the company

Delivers excellence in providing product innovation, customer focus, research to real-life solutions and medicines that improve and save lives. Our client set a space where you can be inspired by the many people who have encouraged and made it their life's work to investigate, develop and educate.

About the Opportunity

The Regulatory Affairs Associate role will hold responsibility for a portfolio of products including many higher-class devices. Reporting to the Regulatory Affairs Manager this will be an autonomous role with a view to developing to people management.

Duties

  • Preparation and submission of regulatory documents for large orthopaedics portfolio for both new and existing products   
  • Develop strong relationships with internal stakeholders and regulators
  • Maintain regulatory databases both departmental and for the wider company source
  • Contribute to industry working groups, assisting to shape the healthcare environment
  • Provide regulatory support during internal and external audits
  • Represent the regulatory department on cross functional project teams
  • Assist in training Regulatory Associates in addition to supporting the wider business with product portfolios

Skills and Experience

  • BSc or BEng with minimum 5 years regulatory experience working with medical devices
  • Regulatory submissions of higher-class medical devices where joint registration would be highly desirable
  • Experience with conformity assessment
  • Familiar with portfolios with a large volume of products
  • Life cycle management
  • Desire to develop to a people manager with the ability to mentor juniors
  • Strong stakeholder management

Culture

Committed to caring, passionate about doing what’s right. A culture that enables dynamic and impactful careers. Thrives on collaboration, inclusion, the sharing and refinement of critical skills and methods.

How to Apply

Click apply or contact Angela Barclay on 02 8877 8743 for a confidential discussion.

 

 

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