Post Market Surveillance
hace 3 semanas
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.
**Your Responsibilities - effective**
- Responsible for all Post Market Surveillance (PMS) activities for medical device Class I, Class IIA and Class IIB medical devices
- Collaborate with colleagues to ensure all post market activities are complaint with the Medical Device Regulation and EN ISO 13485.
- Evaluate and improve as needed processes of vigilance and post market surveillance
- Create, document and analyze complaints for reporting requirements.
- Conduct data analysis for complaints and other KPIs for vigilance
- Create Trend reports for the specific observation period.
- Collaborate with multiple project leaders, specialist for post market compliance.
- Participate in vigilance audits, inspections, and corrective/preventive actions.
- Create statistical reports for vigilance, clinical and post market activities
- Update technical documentation regularly for post market, clinical and technical data.
- Keep vigilance contact person tracker up-to-date and share updates with relevant teams.
- Monitor and interpret changes in global regulations and communicate the impact on the company's products and operations.
- Communicate with Notified Bodies, Health Authorities, Customers and internal stakeholders.
- Develop or contribute to training materials related to vigilance, clinical and medical affairs.
- Train required stakeholders in Standard Operating Procedures.
- Share best practices and updates during team meetings.
- Inform management of emerging issues affecting product safety or requiring reporting to health authorities.
- Review scientific literature data based and adverse events databases and compile quarterly reports.
**Know How**
- Demonstrated knowledge of Medical Device Regulation and EN ISO 13485
- Knowledge all required guidelines for vigilance, PMS and clinical affairs
- Demonstrated strong statistical analytical skills
**Your Profile - impressive**
- Degree in Medical, Clinical, Engineering, Chemistry or any related life science degree
- Minimum 10 years of experience in Medical Devices Industry with vigilance and post market
- Demonstrated leadership and communication skills.
- Strong interpersonal skills and the ability to communicate effectively in English
- Ability to maintain a keen attention to detail and manage multiple projects or tasks concurrently.
- Good MS Office especially Word, and Excel and problem-solving skills
- Independent, assertive, good project management skills, and eager to learn
**Our Commitment to Diversity and Inclusion**
Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability.
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