Sr Manager, Regulatory Operations

Hologic•Newark, NJ

About The Position

The Senior Manager, Regulatory Operations provides strategic and operational leadership to ensure compliant, efficient and scalable regulatory processes. This role is responsible for key regulatory operational areas including labeling, post-market regulatory reporting, state licensing and regulatory agency account maintenance, and Unique Device Identification (UDI) governance. This role ensures global compliance with regulatory requirements while enabling efficient, scalable processes that support a growing medical device portfolio. Provides counsel to and manages the regulatory team. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements. Establishes operational objectives and work plans, and delegates assignments to subordinate managers. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect. Manages activities of two or more sections of departments. Exercises supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors.

Requirements

Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, EU MDD/MDR regulations and relevant global regulations related to medical devices.
Strong knowledge in medical device labeling requirements and previous experience leading a labeling function preferred
Computer literate; able to use word processing, spreadsheet programs, databases.
Excellent ability to read, analyze and interpret professional journals, technical procedures, and government regulations.
Strong ability to effectively present information and respond to questions from senior management, function heads, managers, supervisors, and all levels of employees.
Excellent interpersonal skills to interact with all levels of the company, sometimes in an adversary role.
Demonstrated success in management role.
Ability to work effectively in a strongly matrixed team-oriented structure.
Excellent communication, interpersonal and relationship management skills
Experience in medical device, pharmaceutical or equivalent regulated industry

Nice To Haves

QA and/or RA certification is beneficial.

Responsibilities

Serve as the Divisional labeling process owner and ensure compliance with global labeling requirements (FDA, EU, and other international regulations).
Oversee end-to-end labeling processes, including development, review, approval, and lifecycle management of product labeling.
Establish and maintain labeling procedures, systems, and controls to ensure accuracy, consistency, and traceability and manage external vendors for translations.
Partner with Quality and Commercial teams to support timely product launches, updates, and changes.
Lead regulatory post-market summary reporting activities including managing timely submission of reports to regulatory authorities (i.e., Periodic Safety Update Report, Health Canada summary report)
Manage regulatory establishment registrations and device listings, oversee US state licensing requirements and maintain regulatory data integrity within external databases including FURLS and Eudamed.
Serve as process owner for UDI compliance and governance across global markets.
Oversee UDI data creation, validation, and submission to regulatory databases (e.g., GUDID, Eudamed).
Leads global standards management process and drives cross-functional collaboration with R&D, Quality, Clinical, and Manufacturing teams to identify, assess, and implement applicable international and regional medical device standards (e.g., ISO, IEC, FDA-recognized); ensures effective communication of requirements, alignment on compliance strategies, and integration of standards into product development and lifecycle processes
Develop, implement and maintain procedures and processes for regulatory operations
Responsible for planning, assigning, and directing work, performance management, facilitating employee development, mentoring and coaching to maximize engagement and productivity.
Directs activities as well as sets goals and objectives for the Regulatory function.
Updates job knowledge by studying trends and developments in Regulatory and Quality.