Sr. Manager Regulatory Affairs
hace 1 semana
As a member of the **European Healthcare Regulatory Affairs team, **your main responsibility is to ensure full compliance to the European Medical Device Vigilance Process for the Ecolab/Anios Medical Device product portfolio and lead the communication to the affected competent authorities and notified bodies, in particular with the ANSM.
- You are the **Business partner** for quality, being the interface between regulatory and quality to ensure that regulatory requirements are properly captured in the QMS and different procedures and defining processes with role and responsibilities across functions
- You provide regulatory support for Medical Device Teams in case of vigilance situations
- Act as PRRC, Person responsible for** Regulatory Compliance **- for Laboratoires Anios, according to Article 15 of REGULATION (EU) 2017/745
- You liaise with notified bodies and **competent authorities **in your area of responsibility- You contribute to** risk assessments**
- You maintain and share your knowledge
**Qualifications, Experience, Knowledge & Competencies**:
- **
Master’s degree in chemistry,** biology, toxicology, quality, engineering or any other related field
- **
3 to 5 years **work experience in regulatory affairs or quality management systems related to Medical Devices
- **
Experienced in dealing with regulatory Agencies** / Notified Bodies (ANSM)
- If not already experienced, ability to develop skills in other regulatory areas other than **Medical Devices, such as biocides, cosmetics and human drugs**
- First proven experience in **leadership, project management, problem solving and team development skills**
- Ability to respond quickly in **emergency situations** related to product registration and public health issues (Vigilance Activities)
- Strong communication skills at executive level
- Demonstrated ability to influence across a matrix environment with multiple stakeholders and competing priorities, in an international environment
- **
Fluent English,** with good written and verbal communication skills. Other European language will be a plus.
- You are rigorous, reactive, proactive, autonomous.
- You are flexible and organized.
The position is preferably based in** Barcelona, Spain.**
**Hybrid **work model
Agree to travel across Europe and possibly other regions
**#li-eu**
**Our Commitment to Diversity and Inclusion**
At Ecolab, we believe the best teams are diverse and inclusive, and we are on a journey to create a workplace where every associate can grow and achieve their best. We are committed to fair and equal treatment of associates and applicants. We recruit, hire, promote, transfer and provide opportunities for advancement on the basis of individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, we 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, disability, or status as a covered veteran.
In addition, we are committed to furthering the principles of Equal Employment Opportunity (EEO) through Affirmative Action (AA). Our goal is to fully utilize minority, female, disabled and covered veteran individuals at all levels of the workforce. Ecolab is a place where you can grow your career, own your future and impact what matters.
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