About Convatec
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit
PositionOverview
The Solution Owner R&D (Regulatory & Quality)is responsible forthe full lifecycle of R&D-related management systems, ensuring alignment with regulatory requirements and operational needs. This role combines technicalexpertisewithstrategicvision tooptimizeprocesses andmaintainsystem integrity across global operations.
Key Responsibilities
1. Design, configure, test, deploy,maintain, and improveapplications.
2. Collaborate closely with QA, IT, and business stakeholders to define system requirementsandsolutions.
3. Orchestrateclear, efficient, and well-documented configurations and scripts, following best practices and compliance standards.
4. Participate in system reviews and validation activities to ensure system quality, regulatory compliance (,GxP, 21 CFR Part 11), and data integrity.
5. Troubleshoot, debug, and upgrade existing systems to ensureoptimaloperations and minimal downtime.
6. Contribute to the full system lifecycle, from requirements gathering and design through deployment, training, and ongoing support.
7. Stay updated with emerging technologies and apply relevant advancements to improve system functionality.
8. Work closely with QA and compliance teams to ensure that applications meet the highest quality and regulatory standards.
9. Assistin project planning, task estimation, and risk identification, proactively addressing potential issues and proposing effective solutions.
10. Provide ongoing support, training, and mentorship to users and administrators
KeyRequirements
11. Minimum of7-8years of experience inIT Systemsoperations, with a focus onregulatoryand Quality Solutions.
12. Proven experience withRegulatory & Quality Systems.
13. Proficient in system configuration,SLAManagementandbusiness stakeholder management.
14. Strong understanding of data management and regulatory requirements (,GxP, 21 CFR Part 11).
15. Experience with software development methodologies (, Agile, Scrum) and system validation practices.
16. Familiarity with database technologies (, SQL) and web services (, REST, SOAP).
17. Experience with version control systems (, GitHub) and change management processes.
18. Excellent problem-solving and analytical skills, with attention to detail and data integrity.
19. Strong communicationand teamwork abilities, with experience collaborating across functional teams.
20. Experience with cloud servicesandtechnologies is a plus.
21. Ability to lead training sessions and support end-users in a regulated environment.
Education/Qualifications
22. AMasters /Bachelor's degree in business, information technology, ora relatedfield. Advanced degrees or certifications are a plus.
23. Itil4, Prince2 orGMPis a plus
Travel Requirements
24. Positioninvolvestravel up to10% of the time, mostly within Europe, Asia Pacific, andtheAmericas.Most trips will include overnight travel.
Languages
25. English
26. Spanish or Portuguese a plus
Workingconditions
27. Remote working model
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.