Manager, Global Regulatory Affairs

Summary

Join Telix Pharmaceuticals, a global radiopharmaceutical company, as the Global Regulatory Affairs - MedTech Manager. Reporting to the General Manager, Medical Technologies, you will oversee all regulatory activities within the medical technologies division, ensuring compliance with global requirements and facilitating market entry of innovative medical devices. This critical role involves developing regulatory strategies, ensuring product safety and efficacy, and collaborating with cross-functional teams. You will be responsible for preparing and executing global regulatory strategies, supporting regulatory filings, participating in agency interactions, and ensuring compliance with guidelines and standards. The position requires a BS in a scientific field and at least 7 years of experience in medical device regulatory affairs. Telix offers competitive salaries, bonuses, equity incentives, generous vacation, paid wellness days, and support for learning and development.

Requirements

• BS in scientific degree (chemistry, biology, pharmaceutical sciences, engineering)
• 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

Responsibilities

• Prepare and execute, 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
• Represent 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
• Support 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
• Monitor global health authority regulations, guidelines, and specifications including but not limited to the FDA, EMA, MDR, Health Canada, to maintain regulatory submission compliance
• Perform 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

Preferred Qualifications

Advanced degree

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development