Post Market Surveillance PMS and Vigilance Manager - Regulatory - Healthcare Division

Ecolab is the global leader in water hygiene and energy technologies and services. Every day we handle important tasks in order to protect our planet and our vital resources. With a global workforce of over 48,000 employees, our company has developed a unique corporate culture; together we make the world cleaner, safer, and healthier.

Ecolab Healthcare is looking for a PMS Manager to join the Healthcare Regulatory Affairs Team for Europe. The Manager is part of the scientific and clinical affairs team dedicated to post market surveillance, clinical evaluation, vigilance, and complaints review.

Responsibilities

1. Responsible for all Post Market Surveillance (PMS) activities for medical device Class I, Class IIA, and Class IIB medical devices.
2. Collaborate with colleagues to ensure all post market activities are compliant with the Medical Device Regulation and EN ISO 13485.
3. Evaluate and improve processes of vigilance and post market surveillance as needed.
4. Create, document, and analyze complaints for reporting requirements.
5. Conduct data analysis for complaints and other KPIs for vigilance.
6. Create trend reports for the specific observation period.
7. Collaborate with multiple project leaders and specialists for post market compliance.
8. Participate in vigilance audits, inspections, and corrective/preventive actions.
9. Create statistical reports for vigilance, clinical, and post market activities.
10. Update technical documentation regularly for post market clinical and technical data.
11. Keep vigilance contact person tracker up to date and share updates with relevant teams.
12. Monitor and interpret changes in global regulations and communicate the impact on the company’s products and operations.
13. Communicate with Notified Bodies, Health Authorities, customers, and internal stakeholders.
14. Develop or contribute to training materials related to vigilance, clinical, and medical affairs.
15. Train required stakeholders in Standard Operating Procedures.
16. Share best practices and updates during team meetings.
17. Inform management of emerging issues affecting product safety or requiring reporting to health authorities.
18. Review scientific literature, data-based and adverse events databases, and compile quarterly reports.

Knowledge and Skills

1. Demonstrated knowledge of Medical Device Regulation and EN ISO 13485.
2. Knowledge of all required guidelines for vigilance, PMS, and clinical affairs.
3. Demonstrated strong statistical analytical skills.

Your Profile

1. Degree in Medical, Clinical Engineering, Chemistry, or any related life science degree.
2. Minimum 10 years of experience in the Medical Devices Industry with vigilance and post market.
3. Demonstrated leadership and communication skills.
4. Strong interpersonal skills and the ability to communicate effectively in English.
5. Ability to maintain keen attention to detail and manage multiple projects or tasks concurrently.
6. Good MS Office skills, especially Word and Excel, and problem-solving skills.
7. Independent, assertive, good project management skills, and eager to learn.

Key Skills

1. Revenue Cycle Management
2. HIPAA
3. Healthcare Management
4. PMBOK
5. Microsoft Outlook
6. Project Leadership
7. Data Management
8. Project Management
9. Affiliate Marketing
10. Project Management Software
11. Supervising Experience
12. Workday