Global Head of Regulatory Affairs, Surgical Workflows

This position is open to candidates in US (east coast timezone preferred) and EUR- compensation based upon location.

Job Overview

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 the global regulatory strategy, securing and maintaining market access, leading regulatory remediation, overseeing regulatory submissions and registrations, and managing critical interactions with regulatory authorities and Notified Bodies.

The position leads the Regulatory Affairs teams across Surgical Workflows and provides clear, risk-based recommendations to senior management. This includes an active role in product-safety and regulatory decision-making, including decisions related to Field Safety Corrective Actions, regulatory reporting and communication with authorities. The Global Head of Regulatory Affairs is responsible for the Regulatory Affairs organizations supporting all manufacturing sites and legal manufacturers within Surgical Workflows. The role has direct and indirect responsibility for the leadership, performance, development and effective coordination of Regulatory Affairs personnel across the business area.

Job Responsibilities and Essential Duties

Regulatory Leadership and Strategy

• Provide strategic leadership and direction for the Surgical Workflows Regulatory Affairs function.
• Define and implement regulatory objectives aligned with the Surgical Workflows strategy, portfolio and business priorities.
• Establish a clear global regulatory strategy covering new products, existing products, portfolio changes and market access.
• Monitor the global regulatory environment and translate emerging requirements into clear business actions and priorities.
• Keep the VP QRC, Surgical Workflows Management Team and relevant executive stakeholders informed about regulatory status, risks and critical decisions.
• Provide clear, risk-based recommendations on matters requiring executive attention, investment or prioritization.

Leadership of the Regulatory Affairs Organization

• Lead and manage the Regulatory Affairs teams across Surgical Workflows, including direct and indirect leadership responsibility.
• Define and develop an effective global RA operating model, with clear accountabilities, governance and interfaces between central, site and in-country RA teams.
• Set expectations, objectives and performance priorities for the RA organization.
• Ensure appropriate RA capacity and capabilities across the business area.
• Identify critical roles and capability gaps and establish robust development, talent and succession plans.
• Build a strong Regulatory Affairs community across the Surgical Workflows legal manufacturers and sites.
• Provide regulatory leadership, coaching and training to RA personnel and relevant cross-functional teams.

Regulatory Submissions and Market Access

• Develop and implement regulatory strategies for new product approvals, registrations and market introductions.
• Ensure the maintenance and renewal of licenses and registrations for the existing product portfolio.
• Oversee regulatory strategies and timelines for product-development and lifecycle-management projects.
• Ensure regulatory pathways, requirements, risks and alternative approaches are assessed early in product-development projects.
• Drive timely escalation and resolution of issues that could affect product registration, market access or commercialization.
• Ensure effective coordination between site RA teams and in-country RA organizations to secure and maintain valid product registrations and certificates.

Regulatory Remediation

• Lead regulatory remediation activities across Surgical Workflows where products, technical documentation, registrations or processes do not fully meet applicable regulatory requirements.
• Establish clear remediation scope, priorities, governance, decision rights, milestones and escalation mechanisms.
• Ensure remediation plans are risk-based, adequately resourced and integrated with Quality, R&D, Operations, Product Management and commercial priorities.
• Oversee remediation of regulatory documentation, product classifications, registrations, labeling, claims and market-access gaps.
• Ensure transparent reporting of remediation progress, risks, dependencies and decisions to senior management.
• Confirm that remediation outcomes are sustainable and appropriately embedded in the Regulatory Affairs organization and quality management system.

Product Safety and FSCA Decision-Making

• Provide senior Regulatory Affairs leadership in the assessment of potential product-safety and regulatory-compliance issues.
• Participate in and, where applicable, lead regulatory decision-making concerning reportability, field actions and Field Safety Corrective Actions.
• Ensure FSCA decisions are timely, risk-based, well documented and aligned with applicable regulatory requirements.
• Provide clear recommendations on regulatory reporting, authority notification, customer communication and market actions.
• Ensure appropriate alignment between Regulatory Affairs, Quality, Medical, Product Management, Legal, Operations and commercial stakeholders.
• Oversee regulatory interactions and commitments connected to FSCAs, recalls, safety notices and other corrective actions.
• Escalate significant patient-safety, compliance and business risks to the appropriate senior-management governance bodies.

Authority and Notified Body Relationship Management

• Develop and manage effective relationships and interfaces 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 with regulatory authorities and Notified Bodies.
• Represent Getinge and Surgical Workflows in interactions with authorities, government entities and relevant industry associations.
• Ensure regulatory commitments made to authorities and Notified Bodies are clearly documented, assigned and completed.
• Establish appropriate strategies and communication cadences for significant compliance, remediation and market-access matters.

Compliance Support

• Collaborate with R&D, Operations, Product Portfolio Management, Quality, Medical, Legal, commercial teams and Corporate Quality and Regulatory functions to address regulatory and compliance challenges.
• Develop effective regulatory strategies and solutions that protect patient safety, maintain compliance and support business continuity.
• Support the development and implementation of effective regulatory processes, standards, governance and tools.
• Oversee execution and adjust priorities or approaches where necessary to achieve sustainable compliance.
• Promote effective cross-functional decision-making and communication across the business area.

Regulatory Intelligence

• Represent Surgical Workflows Regulatory Affairs within the corporate Quality and Regulatory organization.
• Collaborate with Corporate Regulatory Affairs on regulatory intelligence and emerging requirements.
• Lead the assessment and implementation of relevant regulatory-intelligence actions across Surgical Workflows.
• Provide independent subject-matter expertise while balancing regulatory requirements, patient safety and business considerations.
• Advise product teams on regulatory requirements related to product development, portfolio changes and acquisition integration.

In-Country Regulatory Compliance

• Ensure continued license to operate in all relevant markets.
• Develop robust registration and re-registration strategies for the Surgical Workflows product portfolio.
• Establish an effective framework for collaboration between site RA teams and in-country RA organizations.
• Ensure the timely availability and quality of regulatory documentation required for registrations, renewals and authority submissions.
• Maintain oversight of critical certificates, registrations, commitments and market-access risks.

Minimum Requirements

• Minimum 15 years of direct Regulatory Affairs experience.
• Bachelor’s degree in science, engineering, technology or another relevant discipline, or equivalent relevant experience.
• Minimum 10 years of direct management experience leading global Regulatory Affairs teams.
• Significant experience within 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.
• Authority
• Authorized to lead Regulatory Affairs personnel across the Surgical Workflows Quality & Regulatory Compliance organization and relevant Getinge entities.
• Authorized to establish regulatory priorities, governance and escalation requirements across the business area.
• Accountable for providing independent regulatory recommendations on market access, compliance, remediation, product safety and FSCAs.
• Financial and employment-related authorities apply within the formally defined authorization framework.

Required Knowledge, Skills, and Abilities

• Extensive expertise in medical-device regulatory pathways, including FDA 510(k), PMA, EU MDR and international product registrations.
• Demonstrated experience in leading complex regulatory remediation programs.
• Strong knowledge of post-market regulatory requirements, regulatory reporting, recalls and FSCAs.
• Experience in direct interactions 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 operate 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.

Supervision/Management of Others

• Direct and indirect responsibility for the management and development of Regulatory Affairs personnel supporting the Surgical Workflows businesses.
• Responsible for defining and developing a robust RA organization aligned with the Surgical Workflows strategic roadmap.
• Responsible for identifying critical positions, strengthening leadership capabilities and establishing talent-development and succession plans.

Internal and External Contacts/Relationships

• Internal stakeholders include:
• Surgical Workflows Regulatory Affairs and Quality teams
• Surgical Workflows Management Team
• R&D, Operations and Product Portfolio Management
• Medical, Legal and commercial functions
• In-country Regulatory Affairs teams
• Corporate Quality and Regulatory functions
• Getinge Executive Committee stakeholders, as applicable
• External stakeholders include:
• Global health and regulatory authorities
• European Notified Bodies
• U.S. Food and Drug Administration
• Other government and regulatory entities
• Relevant industry and trade associations

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions
• May work extended hours during peak business cycles
• The role requires international travel. Travel anticipated to average 25% annually but may vary depending on business needs

Special Requirements

• Global responsibility across Surgical Workflows businesses, legal manufacturers, locations and sites.
• Domestic and international travel is required.
• The position may be remote or hybrid, depending on business requirements.
• Extended working hours may occasionally be required during critical regulatory matters, authority interactions, remediation activities or field actions.

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