Sr Regulatory Affairs Specialist – Medical Device

Intepros; United States; Remote; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

IntePros partners with a leading global medical device company to hire a Sr Regulatory Affairs Specialist focused on international regulatory submissions and regulatory assessments for high-risk implantable devices. The role requires collaboration with cross-functional teams to ensure global regulatory compliance and timely renewals.

The remote, contract position supports regulatory strategy across regions and offers opportunity for extension or conversion based on performance and business needs.

Qualifikationen

• Regulatory affairs experience in the medical device industry.
• Experience with Class III or high-risk implantable medical devices.
• Experience supporting international regulatory submissions.
• Familiarity with medical device regulatory systems and processes.

Aufgaben

• Prepare and coordinate documentation for international regulatory submissions outside the US and EU.
• Support regulatory assessments and change control processes for Class I, II & III implantable medical devices.
• Compile materials for regulatory submissions, renewals, and registrations.
• Collaborate with quality, clinical, engineering, and manufacturing teams.
• Recommend updates to labeling, manufacturing processes, and documentation for regulatory compliance.
• Monitor regulatory changes and maintain tracking and documentation systems.

Kenntnisse

Regulatory affairs

Medical devices

International submissions

Class III devices

Ausbildung

Bachelor's degree

Jobbeschreibung

Job Title: Sr Regulatory Affairs Specialist – Medical Device

Location: Remote

Employment Type: Contract (6–12+ months, potential for extension or conversion)

Work Authorization: W2 only (No C2C)

IntePros is partnering with a leading global medical device company to hire a Sr Regulatory Affairs Specialist to support regulatory activities for high-risk implantable devices. This role will focus on international submissions, regulatory assessments, and change control activities while working closely with cross-functional teams to ensure global regulatory compliance.

Key Responsibilities

• Prepare and coordinate documentation for international regulatory submissions outside the US and EU
• Support regulatory assessments and change control processes for Class I, II & III implantable medical devices
• Compile materials for regulatory submissions, renewals, and registrations
• Collaborate with quality, clinical, engineering, and manufacturing teams
• Recommend updates to labeling, manufacturing processes, and documentation for regulatory compliance
• Monitor regulatory changes and maintain tracking and documentation systems

Requirements

• Bachelor’s degree required
• 4+ years of Regulatory Affairs experience in the medical device industry
• Experience with Class III or high-risk implantable medical devices
• Experience supporting international regulatory submissions
• Familiarity with medical device regulatory systems and processes

This is a great opportunity to support regulatory strategy for innovative medical devices while working with a highly collaborative global team.