Remote Director of Global Regulatory Affairs Jobs
Remote Director of Global Regulatory Affairs jobs are open across the U.S. in life sciences, pharmaceuticals, medical devices, and biotechnology, with opportunities at both large multinational firms and growth-stage companies operating distributed regulatory teams. Employers hiring remotely right now include Takeda Pharmaceuticals, Amgen, and Dechra. Scan the live roles below and apply to whichever ones fit.
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Global Head of Regulatory Affairs, Surgical Workflows
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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.
- 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.
- 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 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
- 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
- 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.
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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Who's Hiring



What Employers Look For
The qualifications that appear most often in remote director of global regulatory affairs jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, or a related field
- Ten or more years of regulatory affairs experience across multiple health authorities
- Proven leadership of global regulatory submissions including CTD and eCTD formats
- Deep knowledge of FDA, EMA, and ICH guidelines and regulatory frameworks
- Experience managing regulatory teams and cross-functional stakeholder relationships
- RAC certification from the Regulatory Affairs Professionals Society preferred
Tips for Your Remote Director of Global Regulatory Affairs Job Search
Apply early to remote roles that fit
Migrate Mate lists remote director of global regulatory affairs openings from companies hiring across the U.S. in one place. Check it regularly and apply directly to roles that match your submission experience and therapeutic area background before postings close.
Demonstrate async regulatory leadership upfront
Remote employers want to see you can run global regulatory programs without daily in-person check-ins. Highlight specific examples of leading multi-region submissions, managing health authority interactions, and coordinating cross-functional teams entirely through written updates and virtual reviews.
Showcase your remote regulatory toolkit
Name the platforms you use to manage regulatory workflows remotely, such as Veeva Vault, Microsoft Teams, and electronic submission systems. Employers evaluating remote candidates want confirmation you operate fluently in distributed regulatory environments without IT hand-holding.
Prepare for competency-based remote interviews
Remote director interviews focus on how you handle ambiguity, prioritize regulatory risk, and maintain alignment with leadership across time zones. Practice walking through a regulatory strategy decision you owned end-to-end, emphasizing how you communicated and documented it without face-to-face access.
Remote Director of Global Regulatory Affairs Jobs: Frequently Asked Questions
How do I get a remote director of global regulatory affairs job?
Target companies with established distributed regulatory teams, such as fully remote biotech firms, global medical device manufacturers, and pharmaceutical companies with offices in multiple countries that coordinate across time zones. Remote employers screen heavily for self-direction, clear written communication, and the ability to manage regulatory submissions and cross-functional stakeholders without in-person oversight. Demonstrated experience with eCTD submissions, global health authority interactions, and remote project management tools gives candidates a concrete edge.
Which companies hire remote director of global regulatory affairss?
Employers currently hiring remote director of global regulatory affairss include Takeda Pharmaceuticals, Amgen, and Dechra, per current remote listings on Migrate Mate as of November 2026. These tend to be remote-first or distributed life sciences companies, pharmaceutical organizations, and medical device firms that operate regulatory functions across multiple geographies without requiring on-site presence.
Can you get a remote director of global regulatory affairs job with no experience?
Yes, but remote director-level roles are harder to land without experience because you must manage complex regulatory programs independently from day one. Entry paths include joining smaller biotech or digital health startups where remote regulatory roles carry broader scope, or moving up from a remote regulatory affairs manager role. Candidates can strengthen their case by showing documented regulatory submissions, regulatory strategy contributions, and experience coordinating async with cross-functional or international teams.
Do you need a degree for remote director of global regulatory affairs jobs?
Usually, but not always in the traditional sense. Most remote employers expect a bachelor's degree in a life sciences, engineering, or related field, and many prefer a master's or RAC certification. What remote employers weigh most heavily alongside formal credentials is a verifiable record of leading regulatory submissions, navigating global health authority interactions, and driving strategy across distributed teams.
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