Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist

About the role

Partner closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements for plasmapheresis devices, drug-device combination products, standalone drug delivery devices, and ancillary devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Represent CSL in official device regulatory capacities and act as an authorized official or responsible person in interactions with regulatory agencies. Promote strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.

Responsibilities

• Support the implementation of regulatory strategies, objectives, and policies for the Global Regulatory Affairs Device function, including defining and optimizing strategies for development, registration, commercialization, and life-cycle management of CSL’s global device portfolio.
• Collaborate with cross-functional colleagues in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions to execute global regulatory device strategies for CSL’s medical device portfolio.
• Directly liaise and negotiate with the US FDA and oversee regional regulatory staff on discussions with international health authorities for device-related matters during development and commercial use.
• Maintain strong, positive relationships with regulators and ensure timely responses to inquiries and requests.
• Author and review high-quality, compliant regulatory documents (e.g., 510(k), De Novo, PMAs, technical documentation for CE mark application, BLAs, MAAs, international device registrations, post-approval variations/supplements, INDs, CTAs, DHFs, Q-submissions, MAFs, and other filings) based on US, EU, and ISO standards.
• Ensure accurate and timely change control assessments of device-related change controls in CSL’s quality management system, including country-specific reporting and submission documentation requirements.
• Advise on regulatory device strategies, solutions to engineering problems, and interpretation of results in the context of device registration requirements aligned with business goals.
• Support global program planning and regulatory device strategy discussions, facilitating communication and flow of regulatory information to stakeholders.
• Perform device regulatory assessments during due diligence for acquisitions, licensing, and partnerships.
• Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSL’s competitive positioning.
• Provide regulatory consultation to internal functions (Plasma Operations, Global Operations, R&D, IT) to support design and implementation of compliant business processes.
• Ensure regulatory policies and procedures are developed and implemented in accordance with international standards.
• Support the creation and execution of regulatory policies, processes, and SOPs that meet global requirements while driving operational efficiency.
• Support outsourcing of regulatory activities, including submission quality assurance, to ensure timely and compliant delivery.

Requirements

• A bachelor’s degree in an engineering or 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 responsibility.
• Extensive experience in the global regulatory device environment, with expertise in pharmaceutical and biotechnological drug development.
• In-depth knowledge of global device regulatory requirements, including 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, QSR, and BIMO compliance.
• 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.
• 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 with health authorities.
• Skilled in motivating, mentoring, and guiding diverse teams within a matrixed organizational structure, fostering 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, aligning regulatory strategy with evolving business needs.
• Ability to use precedent and experience to develop innovative and flexible approaches to achieve goals.

Skills

• Ensures Accountability: Follows through on commitments, acts with ownership, and establishes clear responsibilities and feedback loops.
• Drives Results: Strong bottom-line orientation, persists despite obstacles, and exceeds goals.
• Drives Vision & Purpose: Articulates vision positively, creates milestones, and fosters organizational energy and optimism.
• Instills Trust: Follows through on commitments, is direct and truthful, and aligns words with actions.
• Communicates Effectively: Adapts communication to diverse audiences, listens attentively, and encourages open expression of ideas.
• Builds Effective Teams: Establishes common objectives, fosters collaboration, and rewards team efforts.
• Drives Engagement: Aligns work with people’s goals, empowers others, and connects contributions to organizational goals.
• Manages Ambiguity: Handles uncertainty and risk, acts without complete information, and remains productive under pressure.
• Collaborates: Works cooperatively across functions, partners with others, and credits contributions.
• Decision Quality: Makes sound decisions with incomplete information, balancing analysis, experience, and judgment.
• Global Perspective: Considers broad, global implications of issues and understands the organization’s position in a global context.
• Being Resilient: Maintains confidence under pressure, handles crises effectively, and bounces back from setbacks.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop, and deliver innovative therapies for people living with conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms—plasma fractionation, recombinant protein technology, and cell and gene therapy—to support continued innovation and address unmet medical needs. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers lifesaving therapies to people in more than 100 countries.

Benefits

For more information on CSL benefits, visit How CSL Supports Your Well-being.