Regulatory Affairs Specialist

A company is looking for a Regulatory Affairs Specialist-Sr.

Key Responsibilities

Prepare and review global regulatory submissions, including US 510(k) and EU technical documentation

Develop regulatory strategies and manage regulatory-driven projects to ensure compliance for product launches

Lead engagement with regulatory authorities and conduct internal and regulatory agency audits

Required Qualifications

Experience in regulatory affairs, particularly with medical devices

Knowledge of global regulations and standards related to medical devices

Ability to develop and maintain Standard Operating Procedures (SOPs)

Experience in providing regulatory training and mentoring to teams

Proven ability to manage regulatory change assessments for product registrations