Role Description We are seeking an experienced Regulatory Affairs professional to lead medical devices and combination products regulatory strategy. In this pivotal role, you will provide expert guidance on regulatory pathways for clinical investigations and marketing authorizations, and serve as the key regulatory representative for our global project teams. The role can be home or office based in various European locations. Key Responsibilities - Develop comprehensive regulatory strategies and technical documentation of medical devices and combination products. - Represent the regulatory affairs function in global project teams and governance meetings. - Lead regulatory interactions with health authorities and notified bodies, including preparation of documentation and coordination of meetings. - Manage regulatory activities throughout the device clinical development lifecycle and marketing authorization. - Maintain global regulatory databases with accurate and current information. - Collaborate with CMC and QA departments on device change control processes and global submission requirements. - Support internal and external audits related to medical device quality systems. - Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions. - Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function. Qualifications - University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline. - Minimum 5+ years of experience in regulatory affairs for medical devices and drug-device combination products. - In-depth knowledge of global medical device regulations, in particular EU MDR. Knowledge of US FDA regulation would be a plus. - Proven experience in global regulatory strategy and technical documentation preparation for EU (e.g., clinical investigations, Notified Body opinions, CE certifications). - Familiarity with medical devices regulatory framework including EU-MDR, ISO 13485 and ISO 14155. - Experience also in vitro diagnostic devices would be a plus. - Strong track record representing companies during regulatory audits and inspections. - Excellent communication and interpersonal skills. - Fluent in English, written and spoken. - Proficiency with regulatory systems including Veeva and TrackWise would be a plus.

• Manage and support a team of managers and employees of different levels. • Responsible for developing and implementing local strategy and leading the day-to-day regulatory affairs on base business operations and new product development projects within the Transfusion Medicine Business Unit. • Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. • Interact with US FDA and/or EU Notified Body regulatory personnel (including Corporate International RA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters. • Responsible for the final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed. • Make judgments about the operational impact of proposed actions, and identify and interact with appropriate resources to successfully achieve company and regulatory strategy objectives. • Reviews/ interprets product-specific regulatory issues that may have a material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment. • Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions. • Identify and/or lead process improvement projects to streamline current activities and increase department efficiencies. • Development goals, such as webinars, reviewing FDA website and articles, reading journals, and attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. • Coach, mentor junior staff. Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes. • Perform other work-related duties as assigned.

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• Provide strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio. • Support clinical trial applications, market registrations, and post approval submissions. • Knowledge of global regulations, guidelines, and regulatory precedent coupled with deep technical knowledge of CMC development and manufacturing processes. • Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment. • Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning. • Lead preparation, critical review, and approval of CMC documents for global regulatory submissions and responses. • Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies. • Provide high quality, timely and clear regulatory advice to project teams.