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

CSL•Waltham, MA

About The Position

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. This role ensures worldwide regulatory device compliance and successful market access across all regions. The specialist will collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as the primary liaison to the US FDA for device matters, and work closely with regional regulatory staff to engage with international health authorities. This role represents CSL in official device regulatory capacities and acts as an authorized official or responsible person in interactions with regulatory agencies. The position 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.

Requirements

A bachelor’s degree in an engineering or scientific discipline, or a related field is required.
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.

Nice To Haves

An advanced degree (e.g., MS, PhD) is preferred.

Responsibilities

Support the implementation of regulatory strategies, objectives, and policies for the Global Regulatory Affairs Device function, including defining and optimizing these for 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, including 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, including 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.