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Regulatory Affairs Manager Emea/apac
hace 2 semanas
Our client is looking for a dynamic and experienced Manager of Regulatory Affairs and Compliance to oversee the Regulatory Affairs functions for the EMEA and APAC regions.
**Your Responsibilities and Impact as Regulatory Affairs Manager will be**:
- Supervising Regulatory Affairs for EMEA and APAC jurisdictions, ensuring adherence to procedures and practices for new product submissions, registrations, change assessments, and more.
- Developing product regulatory strategies and overseeing their execution for timely product launches in EMEA and APAC markets.
- Assessing technical documentation updates and coordinating submissions to regulatory agencies across key markets.
- Managing relationships with Economic Operators and acting as the primary point of contact for Regulatory and Compliance matters.
- Leading the change review process, monitoring global regulatory changes, and ensuring timely compliance updates.
- Participating in Change Control Process (CCP) and Management Review (MR) forums for EMEA and APAC.
- Providing support to subsidiary companies in EMEA and APAC for their interactions with Regulatory Agencies.
**Skills, experience and interests you will need to succeed in this role**:
- University Degree in an applied science or related area, or equivalent experience.
- 8+years of experience in Quality Systems for Medical Devices.
- Minimum of 6 years of regulatory affairs experience, with at least 3 years in a management capacity.
- Significant experience in implantable devices, including familiarity with EU MDR Annex XVI devices.
- Knowledge of product registrations in China.
- Native level of English; proficiency in additional languages (Spanish, French, Portuguese or Korean) is a plus.
- Having knowledges of relevant regulations, including ISO 13485, FDA 21 CFR Part 820, EU MDR, UK MDR, and more.
- Excellent communication skills, both oral and written, with the ability to collaborate across interdisciplinary teams.
- Ability to handle confidential information with discretion.
**What´s in it for you?**
- Competitive salary
- Great career perspectives
- Work in an international environment
- Collaborating with internal and external international stakeholders
- Permanant contract (40 hours form Monday to Friday)
