Manager, Global Regulatory Affairs - MedTech

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Reporting to the General Manager, Medical Technologies the Manager, the Global Regulatory Affairs - MedTech will oversee all regulatory activities within the medical technologies division, ensuring compliance with global regulatory requirements and facilitating the approval and market entry of innovative medical devices. This role is critical in navigating complex regulatory landscapes, supporting in developing regulatory strategies, and ensuring our medical technology products meet the highest standards of safety and efficacy. The Regulatory Lead will work closely with R&D, quality assurance, clinical affairs, and marketing teams to ensure regulatory alignment throughout the product lifecycle.

Key Accountabilities:

• Prepares and executes, in collaboration with other regulatory affairs team members, global regulatory strategies and submission requirements pertaining to assigned projects aligned to the objectives and initiatives of the MedTech business.
• Represents regulatory affairs on MedTech project teams as a subject matter expert by providing guidance and regulatory expertise in support to product development and product life-cycle management.
• Support the preparation, submission, and maintenance of regulatory filings, including premarket notifications, regulatory submissions, technical files, and design dossiers.
• Participate in regulatory agency interactions including, but not limited to, redaction of briefing package, preparation of meeting minutes and responses to notified bodies, ministries of health and health agencies and their questions pre- and post-product approval.
• Supports regulatory assessments for change management and ensures compliance of the regulatory submissions by filing and/or coordinating regulatory amendments in relation to the change, where applicable.
• Ensure compliance with relevant regulatory guidelines and standards, including FDA, EU MDR, ISO 13485, ISO42001, ISO27001 and other global regulations.
• Monitors global health authority regulations, guidelines, and specifications including but not limited to the FDA, EMA, MDR, Health Canada, to maintain regulatory submission compliance.
• Performs any other regulatory tasks assigned by the Global Regulatory Associate Director and/or the Global Regulatory Vice-President.
• Collaborate with cross-functional teams, including R&D, quality assurance, clinical affairs, and marketing, to ensure regulatory requirements are integrated into product development and lifecycle management.
• Develop and manage regulatory documentation, including 510(k)s, CE Mark, IDEs, labeling, instructions for use, and promotional materials, to ensure compliance with regulatory requirements.
• Provide regulatory expertise and support to internal teams and external partners, ensuring effective communication and understanding of regulatory requirements as they relate to medical technologies including but not limited to Software, Artificial Intelligence, algorithms, hardware, etc.
• Develop and implement risk management strategies to mitigate regulatory risks and ensure business continuity

Education and Experience:

• BS in scientific degree (chemistry, biology, pharmaceutical sciences, engineering)
• Advanced degree a plus
• A minimum of 7 years’ experience in regulatory for Medical Devices like software as a medical device, robotic surgical platforms, etc.)
• Direct experience in writing regulatory sections for regulatory submissions in the EMA, US and APAC regions)
• Experience across product lifecycle (i.e., development to post-marketing)
• Comprehensive knowledge of medical device development under ISO:13485
• Ability to understand and interpret regulations and guidance documents

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills