Apply: Quality and Regulatory Affairs Manager

•      Leading medical device business 

•      Reporting to the Director, Member of Executive Leadership team 

•      Quality and Regulatory Affairs Manager. Heavy focus on regulatory affairs


Client Details

Medical and patient technology company based in Sydney. 

Description

You will join the senior leadership team ensuring strategic alignment to support the business growth from a Quality and Regulatory perspective. You will provide expertise across quality and 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:

Regulatory Affairs:

• 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

Quality Responsibilities:

• Maintain, advise and report on compliance to the Corporate Quality System, International and Local Requirements and Regulations as well as Quality Policies and Procedures.
• Promote and develop quality awareness in every employee, while helping the site organisation towards improved quality performance and ownership as well as customer and regulatory/compliance oriented initiatives.
• Embed quality into the thinking of all senior leaders across Operations, Regulatory Affairs and link closely with sales and marketing regarding NCR, CAPA activities.

Profile

You will possess a deep and extensive knowledge of medical devices both from a Quality Systems and Regulatory affairs perspective. Specifically, you will have the following:

• Deep knowledge of ISO quality systems (ISO9001 and ISO13485) and proven experience of managing them regards a complex and high-risk medical device portfolio.
• Absolute expertise regards regulatory affairs and product registrations gained from within a 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

• Attractive salary and annual bonus
• 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

Click the 'Apply Now' button ASAP! If you have any questions or would like to have a confidential discussion, please call Matt Walker in our Sydney Office on 02 9195 2381