Regulatory Affairs Manager - Marseille, France - Barrington James

Barrington James

Entreprise vérifiée

Marseille, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

Marseille, France

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 postmarket 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 uptodate with changing regulations and industry trends, and provide guidance to internal stakeholders on the impact of regulatory changes.
Collaborate with crossfunctional 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 crossfunctional teams and regulatory authorities.
Strong analytical and problemsolving 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.

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