Regulatory Affairs Manager - Projects

Overview

Device Technologies has dedicated itself to improving patients' lives through leading edge technology and services, supplying hospitals and healthcare professionals with high-calibre medical solutions from around the world. With HQ in Sydney, the company represents over 200 trusted brands and employs over 1000 highly skilled staff across Australia, New Zealand and Asia. Our culture focuses on productivity, continuous improvement, career development and leadership nurturing to foster a superior workforce.

The opportunity

This is a new position dedicated to growing regulatory needs of Device Technologies Group companies. In this role you will bring exceptional regulatory and project management skills together with people leadership and risk management to ensure subsidiary companies and integration projects meet complex regulatory compliance.

Key Responsibilities

• Ensure Device Technologies products are in compliance with Australian and New Zealand regulatory requirements
• Engage with Device Technologies core and subsidiary business stakeholders to ensure regulatory compliance of their activities, perform gap analysis and support their regulatory needs
• Liaise with subsidiary companies and/or manufacturers to review technical files and ensure complete regulatory compliance in the target region
• Execute complex regulatory applications, primarily with the TGA for medical devices, to gain local approval within a target timeframe. This may also include combination or IVD medical devices, systems or procedure packs.
• Assess and advise on regulatory requirements for new product types to Device Technologies or subsidiaries after contractual agreements have been signed
• Design, lead and participate in improvement or regulatory change initiatives and implementations involving the RAQA Pre-market, Post-market, QA teams and/or wider business/subsidiaries e.g. up-classifications, MDR/UDI/SLK regulatory change implementations, systems development, auditing, or reporting requirements as required to meet the business objectives
• Develop and maintain internal resources/guidance/training documentation on complex regulatory topics to enable cross-training and streamlining of regulatory processes of Device Technologies and Subsidiaries
• Develop and maintain excellent working relationships with relevant regulatory bodies and government departments
• Participate in internal and external audits of Device Technologies and its subsidiaries as required
• Provide support, training, coaching, mentoring and leadership:
  • to direct reporting RAQA team members
  • to RAQA team members in specialized knowledge areas and with the intention to increase the knowledge and effectiveness of the team;
  • on complex regulatory topics and manufacturing requirements as needed
• Assist RAQA Leadership through identification of training requirements of the RAQA team
• Peer-review regulatory applications, audits, files and reports prior to submission to the TGA/Medsafe or other local regulator, as required to ensure accuracy, completeness and successful lodgment
• Collaborate with RAQA Management team and Business Management to ensure effective and timely regulatory applications in the target region
• Approval authority for RAQA departmental functions achieved according to demonstrated competencies
• Liaise with both local and overseas suppliers/manufacturers on regulatory issues and to obtain required documentation for regulatory compliance and new applications
• Maintain accurate and up to date system records, technical files, databases, spreadsheet and registers to demonstrate regulatory compliance
• Collaborate with and support internal sales and marketing teams with required regulatory information for customer tenders and enquiries
• Action internal requests for new products, non-conforming quarantined product investigations or release, advertising compliance reviews, etc.
• Action external requests from the regulator for auditing, reporting or recall purposes, etc.
• Promote the core values and behavioral code of Device Technologies
• Assist RAQA Management and RAQA Team with other functions as required

About you

At Device Technologies, we succeed through our commitment to five key values:

Delivering Innovation - We constantly seek new ideas, technologies, and approaches to meet evolving customer needs and market demands. Through our innovation we continually adapt and transform for our people, our customers and our future success.

Seeking Collaboration - By embracing collaboration we tap into diverse perspectives, skills, and resources to drive innovation, solve complex problems, and achieve common goals.

Taking Ownership - We embrace accountability and initiative. It fosters trust, collaboration, and empowers our people to drive success through proactive responsibility.

Practising Good Business - We strive to embody integrity, responsibility, and sustainability. It involves ethical conduct, transparency, and a commitment to social and environmental stewardship.

Championing the Customer - By placing customers at the heart of decision-making and operations, we enhance experiences, foster loyalty, and collectively strive to improve patient outcomes.

Our ideal candidate aligns with these values and will have 8+ years of experience in the Australian Therapeutic Goods industry, with proven success in regulatory approvals for complex medical device applications and lifecycle compliance. You will be passionate about innovation in patient care, people leadership, mentoring and development of large cross-functional teams. You will be a natural communicator and problem solver, driven by deadlines and thriving in a fast-paced environment.

Experience required

• Tertiary qualification in a relevant field (e.g., Medical Science or Engineering, etc.)
• Minimum 8 years' experience in a diverse range of products within the Australian Regulatory Affairs environment for Class I-III Medical Devices and other specialty products
• Knowledge and experience in applying quality management systems to medical devices manufacture
• Proven success in regulatory submissions for products with complex requirements
• Formal Project Management experience and training
• Medical Device manufacturing experience in an ISO 13485 QMS
• Internal and external auditing and Quality Assurance experience
• Experience with SAP, Adobe Professional, SharePoint and Wrike
• Experience onboarding/offboarding, performance discussions and KPI reporting

Interested?

To apply for this opportunity, please click on the 'apply' button to be redirected to our candidate application portal.

Device Technologies is committed to equal opportunity employment. We will consider all qualified applicants without regard to race, gender, sexual orientation, religion, ethnicity, disability, age or any other protected characteristics.

Please note: Device Technologies will undertake pre-employment checks via our accredited background check provider. An offer of employment will be subject to identity checks, reference checks, right to work, and police integrity checks. Some roles may require additional certifications or vaccination status information, requested during the interview process.

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Device Technologies acknowledges Traditional Custodians of Country across this continent and recognises the continuing connection to land, water, and sky. We pay our respects to all First Nations Peoples and Elders past and present.