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

The Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist is responsible for: 

• Partnering 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. 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, and closely work regional regulatory staff to engage with international health authorities. 
• Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with regulatory agencies. 
• This role promotes 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.

Main Responsibilities and Accountabilities 

• Support the implementation of regulatory strategies, objectives, and policies for the Global Regulatory Affairs Device function. This includes defining and optimizing regulatory strategies, objectives, and policies that govern and support the 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 assigned activities within global regulatory device strategies for CSL’s medical device portfolio, including plasmapheresis devices, drug-device combination products, standalone drug delivery devices, and ancillary devices.  
• Directly liaise and negotiate with the US FDA and oversee and advise regional 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 ensure timely responses to inquiries and requests. Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management. 
• Author and review 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. 
• Ensure accurate and timely change control assessments of change control notifications in CSL’s quality management system for device-related change controls. This includes the country-specific reporting category and detailed 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 the business need and goals. 
• In collaboration with respective CSL stakeholders, support the global program planning and regulatory device strategy discussions. This includes facilitating the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant 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 for its 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 and procedures are developed and implemented in accordance with applicable international standards and requirements. 
• Support the creation and execution of regulatory policies, processes, and SOPs that meet global regulatory requirements while driving operational efficiency and effectiveness across Plasma Operations, Global Operations, and R&D, and stakeholder network. 
• Support the outsourcing of regulatory activities, including submission quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements. 

Position Qualifications and Experience Requirements 

Education & Experience 

• 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 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, 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 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. Attentively listens to others; Adjusts to fit the audience and the message; Provides timely and helpful information to others across the organization; Encourages the open expression of diverse ideas and opinions. 
• Builds Effective Teams:  Establishes common objectives and a shared mindset; Creates a feelings of belonging and strong team morale; Shares wins and rewards team efforts; Fosters open dialogue and collaboration among the team. 
• Drives Engagement:  Structures the work so it aligns with people's goals and motivators; Empowers others; Makes each person feel his/her contributions are important; Invites input and shares ownership and visibility; Shows a clear connection between people's motivators and the organizational goals. 
• Manages Ambiguity:  Deals comfortably with the uncertainty of change; Effectively handles risk; Can decide and act without the total picture; Is calm and productive, even when things are up in the air; Deals constructively with problems that do not have clear solutions or outcomes. 
• Collaborates:  Works cooperatively with others across the site, matrix, network and enterprise to achieve shared objectives; Represents own 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 uses appropriate decision-making criteria and principles; Recognizes when a quick 80% solution will suffice. 
• Global Perspective:  Looks toward the broadest possible view of an issue or challenge; Thinks and talks in global and network terms; Understands the position of the organization within a global, network and enterprise context; Knows the impact of global trends on the organization.  
• Being Resilient:  Is confident under pressure; Handles and manages crises effectively; Maintains a positive attitude despite adversity; Bounces back from setbacks; Grows from hardships and negative experiences.