Senior Regulatory Affairs Specialist

A company is looking for a Senior Regulatory Affairs Specialist (Remote). Key Responsibilities Develop and implement regulatory strategies for timely approvals from global regulatory bodies Prepare and submit regulatory documentation for Class IIa, IIb, and III medical devices, including technical files and design dossiers Provide regulatory guidance to cross-functional teams and maintain relationships with regulatory agencies Required Qualifications Bachelor's degree with a minimum of 4 years or an advanced degree with at least 2 years of regulatory experience in medical devices, biotech, or pharmaceuticals Experience with 21 CFR 820, ISO 13485, and EU Medical Device Regulations Knowledge of SaMD and Digital Health applications Experience in regulatory submissions for new products and changes Understanding of product development processes and design control related to medical device regulations

Apr 30, 2025 - 05:34

A company is looking for a Senior Regulatory Affairs Specialist (Remote). Key Responsibilities Develop and implement regulatory strategies for timely approvals from global regulatory bodies Prepare and submit regulatory documentation for Class IIa, IIb, and III medical devices, including technical files and design dossiers Provide regulatory guidance to cross-functional teams and maintain relationships with regulatory agencies Required Qualifications Bachelor's degree with a minimum of 4 years or an advanced degree with at least 2 years of regulatory experience in medical devices, biotech, or pharmaceuticals Experience with 21 CFR 820, ISO 13485, and EU Medical Device Regulations Knowledge of SaMD and Digital Health applications Experience in regulatory submissions for new products and changes Understanding of product development processes and design control related to medical device regulations