Senior Manager, Global Device Quality

Viatris; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Excellent career progression

Work‑life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a Global Device Quality professional to lead regulatory compliance and quality system programs across multinational regulatory regimes. The role emphasizes collaboration with planning, IT, and master data teams to support global device quality initiatives.

The candidate will drive CAPA, post‑market surveillance, and PRRC responsibilities, while leading cross‑functional teams to ensure alignment with EU MDR, FDA, and CE conformity assessment activities.

Qualifications

• Extensive experience in global cGMP regulations and quality systems across US FDA, EU, Health Canada and AUS/NZ regulatory environments.
• Strong working knowledge of medical device and combination product regulatory requirements, including EU MDR, FDA regulations, 510(k) submissions and CE conformity assessment activities.
• Experience leading quality and compliance functions within pharmaceutical and medical device organisations, including management of third‑party suppliers and external partners.
• Proven ability to interpret and apply regulatory requirements, lead complex compliance discussions and drive corrective and preventive actions across cross‑functional teams.
• Strong leadership and people management experience, including performance management and team development.
• Effective written and verbal communication with regulators, auditors, senior stakeholders and business partners.
• Proficient in Microsoft Office applications.

Responsibilities

• Provide leadership and drive continuous improvements in quality system practices to meet global regulatory requirements.
• Align with top-level managers on corporate-wide quality initiatives and targets.
• Serve as an expert in QMS and conformity assessments for devices and combinations products.
• Evaluate and implement systems for standardized compliant practices with global oversight.
• Support global inspection preparedness, audits, and CAPA activities.
• Interact with regulators in a professional manner while leading submissions.
• Ensure post-market surveillance and vigilance requirements are met (EU & US).
• Act as PRRC where applicable and collaborate on integration activities.
• Monitor regulatory trends and identify best practices for governing QMS.
• Create and improve SOPs and policies to stay compliant with standards.

Skills

Regulatory leadership

Stakeholder engagement

Quality management

Office suite

Tools

Microsoft Office

Job description

The Role & What You Will Be Doing

Global Supply Chain Planning Master Data Analyst is responsible for defining, governing, and maintaining high-quality planning master data across SAP and advanced planning systems in support of global supply chain operations. The role ensures planning data is fit for purpose, supports standardised global processes, and drives effective planning, execution, and reporting — including active involvement in SAP S/4HANA transformation. It requires close collaboration with Planning, IT, Data Quality, and Master Data teams across system deployments, testing, and data migrations.

Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, Global Device Quality will make an impact.

Key responsibilities for this role include:

• Provide leadership and drive continuous improvements in quality system practices throughout the corporation to meet/exceed global regulatory requirements for medical devices and combination products.
• Align with other top-level managers in the development and establishment of corporate-wide Quality initiatives, continuous improvement programs, and key performance targets.
• Serve as a subject matter expert regarding best practices in Quality Management Systems and Conformity Assessments for medical devices and combination products.
• Evaluate, implement, and execute systems for standardizing compliant practices. Provide global oversight of standardized systems and perform "in use" verification of such global systems.
• Participate in activities in support of global inspection preparedness, audit response and CAPA related to local and global systems impacting medical devices and combination products.
• Interact with Regulatory Authorities (Health Authorities and Notified Bodies) in a thoughtful and professional way, while leading medical device submissions and notified body interactions.
• Ensure compliance with medical device post-market surveillance and vigilance requirements (EU & US).
• Act as Person Responsible for Regulatory Compliance (PRRC).
• Collaborate with quality colleagues and other departments during all phases of integration activities, including the assessment of documents, processes, and systems.
• Monitor regulatory trends and identify industry “best practices” for relevant medical device and combination products and governing QMS.
• Create, review and continually improve global medical devices and combination product SOPs and policies to ensure global approach remains compliant and in line with state of the art.
• Review and/or approve site SOPs to ensure alignment with global policies and procedures, and applicable standards and regulations.

The minimum qualifications for this role are:

• Extensive experience in global cGMP regulations and quality systems across US FDA, EU, Health Canada and AUS/NZ regulatory environments.
• Strong working knowledge of medical device and combination product regulatory requirements, including EU MDR, FDA regulations, 510(k) submissions and CE conformity assessment activities.
• Experience leading quality and compliance functions within pharmaceutical and medical device organisations, including management of third‑party suppliers and external partners.
• Proven ability to interpret and apply regulatory requirements, lead complex compliance discussions and drive corrective and preventive actions across cross‑functional teams.
• Strong leadership and people management experience, including performance management, team development, hiring and organisational planning.
• Effective written and verbal communication skills with the ability to engage confidently with regulators, auditors, senior stakeholders and business partners.
• Proficient in Microsoft Office applications including Word, Excel and Outlook.

Benefits At Viatris

• Excellent career progression opportunities
• Work‑life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. For more information, visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, visit https://www.viatris.com/en/about-us/corporate-responsibility

Viatris is an Equal Opportunity Employer.