Global Head of Regulatory Affairs, Surgical Workflows

Getinge•Wayne, NJ

About The Position

The Global Head of Regulatory Affairs, Surgical Workflows provides strategic and operational leadership for the Regulatory Affairs function across the business area. The role is accountable for establishing and executing global regulatory strategy, securing and maintaining market access, leading regulatory remediation, overseeing submissions and registrations, and managing critical interactions with regulatory authorities and Notified Bodies. The position leads Regulatory Affairs teams across Surgical Workflows and provides risk-based recommendations to senior management. It participates in product-safety and regulatory decision-making, including Field Safety Corrective Actions (FSCAs), regulatory reporting, and communications with authorities. The role is responsible for Regulatory Affairs organizations supporting all Surgical Workflows manufacturing sites and legal manufacturers, with direct and indirect responsibility for personnel leadership, performance, development, and coordination. The position has global responsibility across Surgical Workflows businesses, legal manufacturers, locations, and sites. It is open to candidates in the United States, preferably in the Eastern time zone, and Europe; compensation is based on location. The position may be remote or hybrid depending on business requirements and requires domestic and international travel, anticipated to average 25% annually but varying with business needs. Extended hours may occasionally be required during critical regulatory matters, authority interactions, remediation activities, or field actions.

Requirements

At least 15 years of direct Regulatory Affairs experience.
Bachelor’s degree in science, engineering, technology, or another relevant discipline, or equivalent relevant experience.
At least 10 years of direct management experience leading global Regulatory Affairs teams.
Significant experience in the medical-device industry or another highly regulated healthcare environment.
Demonstrated experience with global product registrations, regulatory authority interactions, and lifecycle management.
Experience leading significant regulatory remediation and complex compliance matters.
Experience supporting or making decisions concerning regulatory reporting, field actions, and FSCAs.
Extensive expertise in medical-device regulatory pathways, including FDA 510(k), PMA, EU MDR, and international product registrations.
Strong knowledge of post-market regulatory requirements, regulatory reporting, recalls, and FSCAs.
Experience directly interacting with global regulatory authorities and Notified Bodies.
Proven ability to develop and execute regulatory strategies across a global organization.
Strong leadership experience managing geographically dispersed Regulatory Affairs teams.
Ability to make and communicate clear, risk-based decisions on complex product-safety and regulatory matters.
Ability to work effectively in a complex, matrixed organization and influence senior cross-functional stakeholders.
Strong executive communication, stakeholder-management, and escalation skills.
Ability to translate regulatory requirements into clear, actionable, and motivating objectives.
Domestic and international travel is required; anticipated travel averages 25% annually but may vary with business needs.
Extended working hours may occasionally be required during critical regulatory matters, authority interactions, remediation activities, or field actions.

Responsibilities

Provide strategic leadership and direction for the Surgical Workflows Regulatory Affairs function and align regulatory objectives with business strategy, portfolio, and priorities.
Establish and execute global regulatory strategies for new and existing products, portfolio changes, and market access; monitor regulatory developments and communicate status, risks, and recommendations to senior stakeholders.
Lead and manage Regulatory Affairs teams across Surgical Workflows, developing the operating model, governance, accountabilities, capacity, capabilities, talent plans, and succession plans.
Provide regulatory leadership, coaching, and training to Regulatory Affairs personnel and relevant cross-functional teams.
Develop regulatory strategies for product approvals, registrations, market introductions, product development, and lifecycle management; oversee license and registration maintenance and renewal.
Ensure regulatory pathways, requirements, risks, and alternatives are assessed early in product development, and escalate and resolve issues affecting registration, market access, or commercialization.
Lead regulatory remediation across Surgical Workflows, establishing scope, priorities, governance, decision rights, milestones, resourcing, and escalation mechanisms.
Oversee remediation of regulatory documentation, product classifications, registrations, labeling, claims, and market-access gaps; report progress and ensure outcomes are sustainable and embedded in the organization and quality management system.
Provide senior Regulatory Affairs leadership for potential product-safety and compliance issues, including decisions concerning reportability, field actions, and FSCAs.
Ensure FSCA decisions are timely, risk-based, documented, and aligned with regulatory requirements; recommend regulatory reporting, authority notifications, customer communications, and market actions.
Coordinate Regulatory Affairs with Quality, Medical, Product Management, Legal, Operations, and commercial stakeholders on safety actions and regulatory matters; escalate significant risks to senior-management governance bodies.
Develop relationships with regulatory authorities and Notified Bodies in key markets, including the United States, Europe, China, India, and Australia; lead or support critical meetings, submissions, responses, and negotiations.
Represent Getinge and Surgical Workflows in dealings with authorities, government entities, and industry associations; document, assign, and complete regulatory commitments.
Collaborate with internal and corporate functions to address regulatory and compliance challenges, implement effective processes, standards, governance, and tools, and support sustainable compliance and business continuity.
Represent Surgical Workflows Regulatory Affairs within the corporate Quality and Regulatory organization and lead assessment and implementation of relevant regulatory-intelligence actions.
Advise product teams on regulatory requirements related to product development, portfolio changes, and acquisition integration.
Ensure continued license to operate in relevant markets through registration and re-registration strategies, coordination between site and in-country teams, timely regulatory documentation, and oversight of certificates, commitments, and market-access risks.
Promote environmental consciousness and safe practices in decisions.