Regulatory Affairs Officer

Job Description

Regulatory Affairs Officer

Dijon Bourgogne-Franche-Comt France (Hybrid)

Regulatory Affairs Officer

We are looking for aRegulatory Affairs Officerto join our team and take ownership ofregulatory submissions product compliance and market approvals. This is a fantastic opportunity to be part of aninnovative companythat is committed to delivering high-qualitymedical devicesto the market.

As aRegulatory Affairs Officer you will be responsible for ensuring compliance withmedical device regulations and standards. You will work closely with theQuality Assurance & Regulatory Affairs Managerto:

Regulatory Strategy & Compliance

• Conductregulatory and normative monitoringfor manufactured products and packaging tracking changes and assessing their impact.
• Develop and implementregulatory strategiesto support product approvals across multiple markets.
• Leadchange control projectsrelated to evolving regulatory requirements.
• Supportinternal audits non-conformity resolution and corrective & preventive actions (CAPA).

Regulatory Submissions & Documentation

• Prepare and submittechnical documentation registration dossiers and market authorization applications.
• Ensure compliance withEU MDR ISO 13485 FDA regulations and other international requirements.
• Maintain and updateregulatory declarations and notifications.
• Monitor approval processes and track product registration status.
• Ensuretimely renewal of market authorizationsto support business continuity.

Post-Market Surveillance & Continuous Improvement

• Participate inpost-market surveillance (PMS/PSUR) activitiesand ensure compliance with reporting requirements.
• Supportcustomer complaint investigations and risk management processes.
• Oversee therelease of finished productsas part of the QARA teams business continuity plan.

Collaboration & Cross-Functional Support

• Work closely withinternal teams including R&D Quality and Supply Chain to ensure regulatory requirements are met.
• Engage withregulatory authorities notified bodies suppliers and external consultantsto support compliance efforts.
• Lead and participate inregulatory project meetings and change control initiatives.

Education & Experience:

• Masters degree inQuality/Regulatory Engineering Biomedical Science or a related field.
• 3 years of experience in Regulatory Affairswithin themedical device industry.

Technical Skills & Expertise:

• Strong knowledge ofmedical device regulations includingEU MDR ISO 13485 FDA 21 CFR 820 and international standards.
• Experience inregulatory submissions technical file updates and market approvals.
• Familiarity withpost-market surveillance vigilance reporting and compliance monitoring.
• Understanding ofrisk management CAPA processes and quality systems.
• Proficiency inproblem-solving toolsto identify and address regulatory challenges.

Soft Skills & Mindset:

• Stronganalytical and problem-solvingabilities.
• Excellentcommunication and interpersonalskills to work with bothtechnical and non-technical stakeholders.
• Highlyorganized detail-oriented and capable of managing multiple projects.
• Ability toadapt to evolving regulatory requirementsand work in a fast-paced environment.

Why Join Us

Work with cutting-edge medical technologiesthat make a real impact on patient lives.

Grow your careerin a supportive and dynamic regulatory environment.

Collaborate with a passionate and driven teamin a company that values innovation and compliance.

If you are looking for a role where you can apply yourregulatory expertise work onglobal submissions and be part of a forward-thinking company we would love to hear from you!