MyCareer+
Regulatory Affairs Specialist - Implantable Medical Devices
MyCareer+, Santa Clara, California, us, 95053
Job Description
About the Company
Join a leading medical device company dedicated to advancing healthcare through innovative Class III implantable medical technologies. The team is committed to delivering life-changing solutions while meeting the highest standards of quality, safety, and regulatory compliance.
Position Overview
We are seeking an experienced Regulatory Affairs Specialist to play a key role in supporting regulatory submissions, managing interactions with government agencies, and ensuring compliance for Class III implantable devices. This role requires deep knowledge of FDA PMA regulations and the ability to work effectively in a collaborative, fast-paced environment.
Key Responsibilities
Author, prepare, and submit PMA supplements including 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports
Review and approve engineering and validation study protocols and reports
Oversee manufacturing change reviews for Class III implantable devices to ensure compliance with regulatory requirements
Collaborate closely with cross-functional teams including Engineering, Manufacturing, and Quality to support product development goals
Maintain expert knowledge of FDA PMA guidance and other relevant regulatory standards
Provide regulatory strategy input to project teams and leadership
Requirements
Qualifications
Bachelor's degree in a scientific or engineering discipline (advanced degree preferred)
Proven experience in regulatory affairs within the medical device industry, specifically with Class III implantable devices
Strong track record of authoring and submitting regulatory documents to the FDA, including PMA supplements
In-depth knowledge of FDA regulations, PMA guidance, and applicable ISO standards
Excellent written and verbal communication skills, with the ability to interface effectively with cross-functional teams and regulatory agencies
Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment
Join a leading medical device company dedicated to advancing healthcare through innovative Class III implantable medical technologies. The team is committed to delivering life-changing solutions while meeting the highest standards of quality, safety, and regulatory compliance.
Position Overview
We are seeking an experienced Regulatory Affairs Specialist to play a key role in supporting regulatory submissions, managing interactions with government agencies, and ensuring compliance for Class III implantable devices. This role requires deep knowledge of FDA PMA regulations and the ability to work effectively in a collaborative, fast-paced environment.
Key Responsibilities
Author, prepare, and submit PMA supplements including 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports
Review and approve engineering and validation study protocols and reports
Oversee manufacturing change reviews for Class III implantable devices to ensure compliance with regulatory requirements
Collaborate closely with cross-functional teams including Engineering, Manufacturing, and Quality to support product development goals
Maintain expert knowledge of FDA PMA guidance and other relevant regulatory standards
Provide regulatory strategy input to project teams and leadership
Requirements
Qualifications
Bachelor's degree in a scientific or engineering discipline (advanced degree preferred)
Proven experience in regulatory affairs within the medical device industry, specifically with Class III implantable devices
Strong track record of authoring and submitting regulatory documents to the FDA, including PMA supplements
In-depth knowledge of FDA regulations, PMA guidance, and applicable ISO standards
Excellent written and verbal communication skills, with the ability to interface effectively with cross-functional teams and regulatory agencies
Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment