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
Regulatory Specialist • Arlington, Texas, United States