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Regulatory Affairs & QA Manager

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Regulatory Affairs & QA Manager

RESPONSIBILITIES AND TASKS

• Act as Representative towards Notified Bodies and Authorities - a credible, influential and respected corporate spokesperson for interactions and negotiations with global regulatory and governmental agencies on regulatory and quality related matters.

• Improve and maintain best-in-class regulatory processes and Quality Management System.

• Anticipate future regulatory changes and impact on business success and take the necessary actions to limit the effect on the company’s business.

• Utilize available resources to drive the decision-making process involving regulatory and quality issues.

• Proactively manage post-market surveillance, complaint handling and vigilance reporting.

• Direct the development and review of technically accurate and cost-effective product / process quality plans for new or modified products.

• Analyse product / process performance data and inspection data; coordinate with the

appropriate function area to reduce or eliminate non-conformances through positive corrective actions.

• Perform Supplier Quality Audits and interact with Purchasing and appropriate Engineering personnel regarding supplier quality issues.

• Proficiency in interpreting EU regulations as they apply to the organisation and other appropriate areas of the company.

• Design, improve and maintain up to date Risk Management Files of existing and in development products.

 

PROFILE

• Bachelor’s or Master’s degree in medical technology, life sciences or similar.

• Minimum 5 years of experience in medical device Quality management and in Regulatory Affairs is required which will have been gained globally with particular emphasis on European Regulatory Authorities. 

• Experience with innovative products or product launches is a strong plus. 

• Sound knowledge of quality standards/regulations and business strategies to improve compliance profile.

Gesamtbewertung

3,7

Basierend auf 30 Bewertungen

2,3 Karriere / Weiterbildung
3,0 Gehalt / Sozialleistungen
3,7 Work-Life-Balance
2,7 Management

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