Regulatory Affairs Manager Emea/apac

hace 6 meses


En remoto, España Blu Selection A tiempo completo

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.

Tasks

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.

**Requirements**:
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.

**Benefits**:
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 contract - from Monday to Friday)

Your future company

Our client is a rapidly growing global team at a renowned global medical technology company. The organization is dedicated to enhancing patient safety and aesthetic outcomes, with a primary focus on the breast aesthetics and reconstruction market. With a robust portfolio of cutting-edge silicone gel-filled breast implants, they are revolutionizing the femtech industry through innovative design, development, manufacturing, and marketing.



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