Director Global Vigilance

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

Every day, our products improve the lives of millions of people around the world. We're hugely proud of this, which is why we're transforming our business to reach millions more. Join us as a Director Global Vigilance and you'll drive progress that really means something.

Director Global Vigilance
Position Overview:
The
Director Global Vigilance
will coordinate and lead all Global Vigilance quality related activities. This role is responsible for developing and maintaining a Global Quality Vigilance activities. This position directly manages the situation analysis (e.g. product risk escalation and resolution), reportability to notified body/competent authorities, Health Hazard Evaluation, and Market Action processes. The Director Global Vigilance provides strategic and tactical guidance on establishment of quality metrics to aid in the monitoring of the health of these processes. This position develops proactive strategies that successfully execute both process improvements and program execution activities vigilance activities.

Key Responsibilities:

• Ensure adequate, appropriate and effective Global Vigilance processes (Market Action, Reportability and Health Hazard Evaluations).
• Ensure compliance to Regional Regulations such as US QSR 820 and EU_MDR.
• Lead the global Vigilance team in execution of activities.
• Lead and coordinate feedback to any authority vigilance related enquiries.
• Partner with business unit (BU) leaders.
• Establish clear roles & responsibilities when liaising with legal, medical, quality, regulatory, operations, engineering, and other functions in the vigilance processes.
• Own dashboard and trend analysis for vigilance KPIs.
• Develop strategy that drives improvements.
• Harmonize & connects global processes for efficiency.
• Identify, hire, train, develop and maintain qualified Quality Vigilance personnel.
• Provide vigilance input and feedback to GQO LT and CELT.

Skills & Experience:

• 5+ years' experience with Vigilance and post market activities.
• Strong experience in the medical device industry, in an international environment in a global position is required.
• 5+ years of experience in a leadership role.
• Experience in interpretation and application of QSR, ISO Standards and other relevant global regulations.
• Knowledge of regulatory requirements that affect the medical device manufacturing business, headquarters' policies and systems in place to achieve conformance.
• Knowledge of regulatory requirements that affect the medical device manufacturing business and puts policies and systems in place to achieve conformance: QSR Part 820, ISO 13485, MDD, MDR, 93/42, ISO 9001, GMP Parts 210 and 211.
• Experience with communications with authorities, notified bodies, executive level.
• Ability to think in a clear, decisive manner, remaining calm under stressful and challenging conditions.
• Ability to efficiently work through quality, organization and business issues with a focus on solutions and proactive contingency planning in support of the customer and business objectives.
• Ability to apply budgetary analysis principles and effective allocation of internal/external resources.
• Understanding of risk management principles and ability to apply these principles in day-to-day quality management activities, compliance issues, and business challenges.

Qualifications/Education:

• Minimum of B.S., or equivalent, in a scientific/technical discipline is required.

This is a
remote role
. This position will require travel up top 20% of the time. This role is based in the UK.

REMOTE

Ready to join us?
At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at

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.

Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you