Regulatory Affairs Manager
Il y a 2 mois
Marseille, France
- 16-05-2023
- JOB TYPE
- Permanent
- EMP TYPE
- Full-Time
- EXPERTISE
- Regulatory Affairs
- SALARY TYPE
- Annually
- SALARY
- Negotiable
Are you a skilled and experienced Regulatory Affairs professional seeking an exciting opportunity in the vibrant city of Marseille? We are a leading medical device company specializing in innovative healthcare solutions, and we are currently seeking a talented Regulatory Affairs Manager to join our team. This is a fantastic opportunity to contribute to the development and success of cutting-edge medical devices while ensuring compliance with regulatory requirements.
**Responsibilities**:
- Serve as the primary regulatory expert, ensuring compliance with local and international regulations and standards for medical devices.
- Develop and execute regulatory strategies for product development, registration, and post-market surveillance.
- Oversee the preparation and submission of regulatory submissions, including CE marking, FDA submissions, and other global registrations.
- Maintain strong relationships with regulatory authorities and act as the main point of contact for regulatory inspections and audits.
- Stay up-to-date with changing regulations and industry trends, and provide guidance to internal stakeholders on the impact of regulatory changes.
- Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product lifecycle.
- Conduct risk assessments and provide regulatory guidance for new product development and design changes.
- Ensure compliance with quality management system requirements, including ISO 13485 and other applicable standards.
- Train and educate internal teams on regulatory requirements and best practices.
**Qualifications**:
- Bachelor's degree in a relevant scientific or engineering discipline. Advanced degree preferred.
- Proven experience (5+ years) in regulatory affairs within the medical device industry, with a strong understanding of European and FDA regulations.
- Extensive knowledge of relevant standards, including ISO 13485, MDR, and IVDR.
- Experience with preparing and submitting regulatory submissions, including CE marking and FDA submissions.
- Familiarity with risk management and quality management systems.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and regulatory authorities.
- Strong analytical and problem-solving abilities, with meticulous attention to detail.
- Ability to manage multiple projects simultaneously and meet tight deadlines.
- Fluency in English and French is required.
We offer a competitive salary and benefits package, along with a collaborative and dynamic work environment where you can make a real impact on improving healthcare outcomes. Marseille is a vibrant city with a rich cultural heritage, offering a high quality of life and a diverse range of recreational activities.
T: +44 1293 776644
LI-TH2
Consultant
- Thomas Hatfield
- +441293776644
-
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