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Regulatory Affairs Manager

•      Leading medical device business 

•      Manager of Regulatory Affairs reporting to the ANZ Director of Quality and RA

•      Operational control across ANZ within Regulatory Affairs 

Client Details

Leader in medical and patient technology based in Sydney. 

Description 

You will report to the ANZ senior leadership team ensuring strategic alignment to support the business growth from a Regulatory Affairs perspective. You will provide expertise across regulatory affairs to the local, regional and international business. Utilising your highly skilled team your remit will be to provide timely approvals for product lines including the management of all product registrations providing accurate updates on product registration and new regulations and ensure compliance to all quality systems, processes and procedures. Specifically, you will cover:
  • Prioritise, plan and execute on product registration and re-certifications. Act as a regulatory representative to influence, negotiate and support successful product submissions with government agencies and regulatory bodies. Providing direction for the team, through interpreting, translating and applying technical, scientific, clinical, quality requirements and regulations
  • Act as a company sponsor to cross functional and cross divisional leaders to communicate and provide understanding of regulatory Partner with sales and marketing and operations to develop and influence sound product and business strategies
  • Guide, coach and develop team in the appropriate application of regulations and standards related to submission preparation and commercialization, product and labelling compliance
  • Develop strong internal and external global relationships
Profile

You will possess a deep and extensive knowledge of medical devices rom a Regulatory affairs perspective. Specifically, you will have the following: 
  • Absolute expertise regards regulatory affairs and product registrations gained from within a (class 3) medical device business.
  • Ability to influence unique and creative solutions to meet customer needs
  • A Tertiary qualified expert in stakeholder management and engagement with the ability to challenge the status quo and corporate thinking.
  • A highly flexible and adaptable approach to management resources and an engaging, empathetic style of leadership with a passion for team development and product delivery.
  • A passion for product and patient delivery and a real desire to improve the lives of people through your work

Job Offer
  • Be part of a senior leadership team where you will be developing and implementing the strategy
  • Work with diverse and high-performance colleagues, tackling some of the most important health industry challenges
  • Be part of an enriching culture born on values, purpose, imagination and spirit
  • Flexible working environment and fantastic staff benefits
  • International travel

 To attract the very best the client is offering a market leading salary + super + car allowance + bonus

Please click APPLY NOW or call Matt Walker on 02 9195 2381