Regulatory Affairs Specialist Implantable Medical Devices

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Posted on : 16-08-2025

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1 Vacancy

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Jobs by Experience

1-3years

Job Location

Santa Clara - USA

Monthly Salary

80 - 80

Vacancy

1 Vacancy

Posted on : 16-08-2025

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

Essential Skills Strong diagnostic acumen across imaging modalities. Exceptional written, verbal, and consultative communication. Ability to thrive in a collaborative, fast-paced clinical setting. Proficiency in PACS, RIS, and EHR systems.

Education

Regulatory Affairs

Employment Type

Full Time

Company Industry

Key Skills

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Regulatory Affairs Specialist Implantable Medical Devices

MyCareer+

Job Description

Requirements

Employment Type

Company Industry

Key Skills

About Company

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