TheHead of GlobalRegulatory Affairs Deviceis responsible for:
Leadingthe global regulatory strategy and execution for CLS’s medical device portfolio during development and post-approval lifecycle, including plasmapheresis devices, blood establishment computer software (BECS), drug device combination products, standalone drug delivery devices, ancillary devices, and software as/in a medical device (SaMD/SiMD).
Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, andclosely workregional regulatory staff to engage with international health authorities.
This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functionsto drive alignment and support CSL’s strategic businessobjectives.
MainResponsibilitiesandAccountabilities
Provide proactive leadership and strategic direction to the GlobalRegulatory Affairs Devicefunction. This includes defining andoptimizingregulatory strategies,objectives, and policies that governand supportthedevelopment, registration, commercialization, and life-cycle managementof CSL’s global medical device portfolio.
Mentor, develop, and coachahigh-performing regulatory affairs team.Foster talent, build team capabilities, and create a culture of continuous learning and professional growth.Provideclear direction, constructive feedback, and career development support within a dynamicworkenvironment.
In closecollaborationwith cross-functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions, define, coordinate and implement global regulatory device strategies for all of CLS’s current and future medical device portfolio, including plasmapheresis devices, blood establishment computer software (BECS), drug device combination products, standalone drug deliverydevices, ancillary devices, software as/in a medical device (SaMD/SiMD).
Directly liaise and negotiate with the US FDA and oversee andadviseregional regulatory staff on discussions with international health authorities and agencies for device-related matters during development and commercial use.Maintain strong, positive relationships with regulators and ensuretimelyresponses to inquiries and requests. Facilitatetimelydecision-making and guidance from health authorities through effective communication and relationship management.
Oversea and direct the creation of high quality, compliant regulatory documents (e.g., 510(k), De Novo, PMAs, technical documentation for CE mark application, initial BLAs and MAAs, international device registrations, post-approval variations/supplements, INDs, CTAs, DHFs, Q-submissions, MAFs and other relevant regulatory filings such as meeting requests and briefing packages) based on relevant US, EU, and ISO standards for the device portfolio within defined timelines as per R&D and commercial objectives.
Provide expert Health Authority feedback including success criteria, risk metrics, pediatric study plan considerations, device feasibility assessments, device selection analyses, clinical trial design input, and human factors (formative/summative) study strategy.
In collaboration with respective CSL stakeholders, support the global program planning and regulatory device strategy discussions. This includesfacilitatingthe communication and flow of regulatory information (regulatory framework,scopeand project timelines) to all relevant stakeholders.
Provide regulatory consultation to internal CSL functions, includingPlasmaOperations,Global Operations functions,R&D,and IT, to support the design and implementation of business processes that ensure regulatory compliance and operational excellence.
Direct the creation and execution ofregulatory policies, processes,and SOPs that meet global regulatory requirements while driving operational efficiency and effectiveness acrossPlasma Operations,GlobalOperations, and R&D,and stakeholder network.
Position Qualifications and Experience Requirements
A bachelor’s degree inan engineering or scientific discipline,or a related field isrequired; an advanced degree (e.g., MS, PhD) isstronglypreferred.
Over 10 years of progressive experience in regulatory roles within themedical device, pharma, or biotechnologicalindustry,demonstratingincreasing levels of responsibility and leadership.
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.
Proventrack recordin leading 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.Provenexpertisein authoring, reviewing, and managing regulatory submissions, ensuring accuracy, compliance, andtimelydelivery.
Experienced in managing FDA and notified body interactions, including formal meetings, audits, and inspections.
Ability to support regional and local Regulatory Affairs teams in interactions with health authorities such as EMA, PEI, AGES, PMDA, and Health Canada.
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.
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;Establishesclear responsibilities and processes formonitoringwork and measuring results; Designs feedback loops into work.
Communicates Effectively:Is effective in a variety of communication settings: one-on-one,smalland large groups, among diverse styles and position levels, with internal and external stakeholders/audiences.Attentivelylistensto others; Adjusts to fit the audience and the message; Providestimelyand helpful information to others across the organization; Encourages the open expression of diverse ideas and opinions.
Collaborates:Works cooperatively with others across the site, matrix,networkand enterprise to achieve sharedobjectives;Representsown interests while being fair to others and their areas; Partners with others to get work done; Credits others for their contributions and accomplishments; Gains trust and support of others.
Decision Quality:Makes sound decisions, even in the absence of complete information; Relies on a mixture of analysis, wisdom, experience, and judgment when making decisions; Considers all relevant factors and usesappropriate decision-makingcriteria and principles; Recognizes when a quick 80% solution will suffice.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our 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 the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
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 its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
