GRA CMC SaMD & Cybersecurity Specialist

**The Lead, Global Regulatory Affairs Device is responsible for:****Main Responsibilities and Accountabilities*** Support the implementation, optimization, and continuous refinement of global regulatory strategies, objectives, and policies for the Global Regulatory Affairs Device function, governing the development, registration, commercialization, and life-cycle management of the company’s global device portfolio, including SaMD/SiMD.* Collaborate with cross-functional partners across Global Regulatory Affair, R&D, Quality, Global Operations, Plasma Operations, IT, and other business functions to execute regulatory strategies for a broad portfolio including plasmapheresis devices, blood establishment computer software (BECS), drug-device combination products, ancillary devices, SaMD/SiMD, mobile applications, and connected platforms.* Serve as the regulatory device subject matter expert for patient-integrated care solutions initiatives, advising and facilitating alignment among diverse cross-functional stakeholders.* Directly liaise, negotiate, and maintain strong, positive relationships with the US FDA, and provide oversight and guidance to regional regulatory staff in discussions with international health authorities (e.g., IMDRF regions) to enable timely decision-making, appropriate agency feedback, and rapid resolution of regulatory inquiries.* Author, review, and ensure delivery of high-quality regulatory documentation—including 510(k), De Novo, PMAs, Q-Submissions/Pre-Submissions (Pre-IND, Pre-BLA), BLAs/sBLAs, MAAs, CTAs, INDs, DHFs, CE technical documentation, international device registrations, post-approval supplements and variations, MAFs, LOAs, technical files, CERs, PMCF documentation, and related briefing packages—in accordance with applicable US, EU, ISO, IEC, and IMDRF requirements.* Apply expert knowledge of key ISO and IEC standards (e.g., ISO 13485, ISO 14971, ISO 10993, IEC 60601-1, IEC 62304, IEC 62366, EN ISO 14981, AAMI HE75) and ensure effective integration into product design, verification, validation, and documentation within 21 CFR 820-aligned design control processes. Demonstrate competency in regulatory submission pathways enabling SaMD/SiMD premarket applications, including FDA 510(k), PMA, Q-Submission meeting preparation, BLA/sBLA facilitation, and EU MDR 2017/745 compliance.* Ensure accurate and timely regulatory change control assessments within the company’s quality management system, including classification of country-specific reporting categories and preparation of detailed supporting submission documentation.* Advise on regulatory strategy, engineering solutions, design control interpretation, cybersecurity requirements for SaMD/SiMD, and human factors integration to align with business needs, patient safety expectations, and global compliance requirements.* Support global program planning activities, providing regulatory framework insight, scope evaluation, and project timeline communication to ensure strong alignment across stakeholders and smooth program execution.* Perform device regulatory assessments and participate in due diligence activities associated with acquisitions, licensing opportunities, and strategic partnerships to inform regulatory risk, remediation needs, and commercial potential.* Leverage external insights, evolving global regulatory intelligence, and innovative approaches to enhance competitive positioning and accelerate regulatory pathways for the device product portfolio.* Provide regulatory consultation to internal CSL functions, including Plasma Operations, Global Operations functions, R&D, and IT, to support the design and implementation of business processes that ensure regulatory compliance and operational excellence.* Ensure regulatory policies, procedures, and work instructions are developed, implemented, and maintained in accordance with applicable international standards, US FDA requirements, EU MDR, and evolving regional regulations.* Support the creation, execution, and continuous improvement of global regulatory policies, processes, SOPs, and best practices that enable operational efficiency and effective oversight across device programs.**Position Qualifications and Experience Requirements****Education & Experience*** A bachelor’s degree in an engineering, computer science, scientific discipline, or a related field is required; an advanced degree (e.g., MS, PhD) is preferred.* Over 5 years of progressive experience in regulatory roles within the medical device, pharma, or biotechnological industry, demonstrating increasing levels of responsibility.* Extensive experience in the global regulatory device environment, with proven expertise in global pharmaceutical and biotechnological drug development.* In-depth knowledge of global device regulatory requirements, including but not limited to: EU MDR, ISO 13485, ISO 14971, ISO 15223, ISO 10993, IEC 62366, IEC 62304, IEC 60601, ISO 20916, ISO 18113, ISO 23640, 21 CFR Part 820, IEC 62304:2006, ISO 14971:2019, IEC/TR 80002-1:2009, IMDRF Software as a Medical Device Framework, QSR and BIMO compliance, and PFSB/MDRMPED for SaMD.* Demonstrated ability to generate successful FDA, EU, and international submissions, including 513(g) requests, pre-submissions, IDEs, 510(k)s, PMAs, De Novo 510(k)s, and EU MDR product registrations. Proven expertise in authoring, reviewing, and managing regulatory submissions, ensuring accuracy, compliance, and timely delivery.* Experienced in managing FDA and notified body interactions, including formal meetings, audits, and inspections.* Familiarity with emerging digital health technologies and evolving cybersecurity requirements.* Demonstrated leadership in managing and developing high-performing teams of regulatory device professionals.* Ability to support regional and local Regulatory Affairs teams in interactions with health authorities such as EMA, PEI, AGES, PMDA, and Health Canada.* Proven capability to develop and implement global device regulatory strategies, resolve complex regulatory challenges, and negotiate optimal pathways and outcomes with health authorities.* Skilled in motivating, mentoring, and guiding diverse teams within a matrixed organizational structure, fostering a culture of accountability and excellence.* Exceptional oral and written communication skills, with a strong ability to negotiate, influence, and represent regulatory positions effectively.* Committed to the highest standards of compliance, integrity, and adaptability, with a strong focus on aligning regulatory strategy with evolving business needs.* Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve goals.* Competencies* Ensures Accountability:

Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.* Drives Results:

Has a strong bottom-line orientation; Persists in accomplishing objectives despite obstacles and setbacks; Has a track record of exceeding goals successfully; Pushes self and helps others achieve results.* Drives Vision & Purpose:

Talks about future possibilities in a positive way; Creates milestones and symbols to rally support behind the vision; Articulates the vision in a way everyone can relate to; Creates organization-wide energy and optimism for the future; Shows personal commitment to the vision.* Instills Trust:

Follows through on commitments; Is seen as direct and truthful; Keeps confidences; Practices what he/she preaches; Shows consistent between words and actions.* Communicates Effectively:

Is effective in a variety of communication settings: one-on-one, small and large groups, among diverse styles and position levels, with internal and external stakeholders/audiences. #J-18808-Ljbffr