Regulatory Affairs Manager EMEA/APAC (English speaker)
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 knowledge 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
- Permanent contract (40 hours from Monday to Friday)
For more information on the role, apply or contact me directly at firstname.lastname@example.org and I will get back to you. All applicants please attach CV in English.