Regulatory Affairs Leader - Medical Device

SYNC Projects by Obelis Group is a consultant firm for global regulations, supporting the medical device and cosmetics industry since 2004.

Role Overview:

Responsible for regulatory affairs activities, including assisting in regulatory submissions, annual reports, registrations, and listings. Assure compliance with applicable medical device regulations, guidance, and standards. Assist in creating and maintaining regulatory files. 

Key Responsibilities:

• Prepare and submit regulatory submissions to health authorities.
• Create and update technical documents that comply with applicable guidance to support regulatory submissions.
• Maintain regulatory files and update regulatory authorizations, dossiers, certifications, and other documents.
• Ensure that all registrations are properly maintained, including renewals, device listings, site registrations, supplements for changes, and annual reports.
• Prepare responses to regulatory authorities as needed.
• Review and assess device-related incidents/complaints for medical device reporting requirements.
• Review labels and other materials to ensure compliance with applicable regulations and standards.
• Provide regulatory input to minimize the potential for findings of non-compliance during external regulatory audits.

Qualifications:

• Bachelor's degree in a related field (advanced degree preferred).
• Minimum of 3 years of experience in regulatory affairs within the medical device industry.
• Strong understanding of global regulatory requirements and standards (FDA, EU MDR, etc.).
• Experience leading regulatory submissions and interactions with health authorities.
• Excellent communication and organizational skills.
• Proven ability to work effectively in a fast-paced, dynamic environment.

Benefits:

• Competitive salary and benefits.
• Opportunity to work in a leading global consultant firm in front of cutting-edge companies in medical technologies.
• Career growth and development opportunities.

If you are a dedicated professional in regulatory compliance and have the experience to excel in this role, we want to hear from you! Join us in our mission to achieve global compliance.

How to Apply:

Please submit your resume and cover letter outlining your qualifications and experience. We look forward to reviewing your application and discussing how you can contribute to our team.