- Develop and execute global regulatory submission strategies for new or existing products to enable product registrations and distribution to markets.
- Develop a strategy to ensure and continuously improve the effectiveness of the organisation including execution of processes, development, and monitoring of relevant metrics.
- Collaborate with designated PPRC to ensure compliance to applicable medical devices product regulations.
- Assess and promote compliance with existing laws and regulations pertaining to medical devices.
- Partner closely with counterparts in Operations, Quality, Supply Chain, Research & Development, Marketing, and Legal to ensure effective execution of the regulatory strategy.
- Support interactions with external agencies such as Notified Bodies, Competent Authorities, and OEM customers on audits.
- Support improvement projects including enhancements to processes, procedures, infrastructure, and digital tools to ensure compliance to applicable regulatory requirements and enable business growth.
- Part of due diligence activities on acquisition targets.
- Lead, develop, engage organizational talent.
- Master degree in a technical field, including engineering, scientific disciplines (ex: chemistry, biology, etc), medicine, and pharmacy, regulatory affairs.
- 10+ years of medical device experience in a manager role implementing requirements such as EU MDR, ISO 13485, ISO 14971 in a complex multi-site business.
- Experience leading remediation programs, resolution of product quality and regulatory compliance matters.
- Experience in product registrations and submission strategies in the EU and global markets.
- Good problem-solving skills.
- Demonstrated grasp of business and regulatory processes
- Excellent written and verbal communication skills in English
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Healthcare Regulatory Manager - Lille, France - Ecolab
Description
JOB DESCRIPTIONEcolab Healthcare is looking for a Regulatory Affairs Manager to join the Healthcare RA Leadership Team for Europe.
The Manager leads a Regulatory Affairs team dedicated to the preparation, maintenance of technical files as well as of innovations and is a key member of the EU RA Healthcare Leadership Team. The Manager leads the regulatory affairs dossiers and registration strategy group and is responsible for executing regulatory submission and compliance strategies to enable business growth.
Key Job Requirements
Minimum Competencies and Qualifications:
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.
