Regulatory Affairs Associate II

The Fountain Group; Irvine (CA); Hybrid; USD 59,000 - 66,000; Full time

Job summary

The Fountain Group in Irvine, CA is seeking a Regulatory Affairs Specialist for medical devices. Hybrid role with onsite Tue/Wed/Thu in Irvine. The role focuses on developing regulatory strategies and managing submissions for EU Class IIb devices across multiple markets.

You will work with R&D, Engineering, Manufacturing, and Regulatory teams to ensure timely approvals and lifecycle management, including post-approval activities and responses to Health Authority questions.

Qualifications

• 3–5 years of direct Regulatory Affairs experience, preferably in medical devices.
• Experience with Class IIb devices in the EU and EU MDR 2017/745.
• Experience authoring, submitting, and obtaining approval of Class IIb variations/renewals.
• International regulatory submissions beyond the U.S. including JAPAC/APAC, MEAR, LATAM.

Responsibilities

• Develop and execute regulatory strategies to support product development and lifecycle management.
• Prepare and support new market applications, renewals, variations, and other submissions.
• Coordinate regulatory activities for manufacturing changes and EU Class IIb devices.
• Provide regulatory guidance to cross-functional teams across R&D, Engineering and Manufacturing.

Skills

Regulatory affairs

Medical devices

EU MDR 2017/745

Documentation management

Job description

Now Hiring: Regulatory Affairs Specialist – Medical Devices

Irvine, CA – Hybrid
Onsite Tuesday, Wednesday & Thursday

Pay: $43-$48/hr

Required Qualifications

• 3–5 years of direct Regulatory Affairs experience, preferably within the medical device industry
• Recent experience supporting Class IIb medical devices in the EU
• Strong working knowledge of EU MDR 2017/745
• Demonstrated experience authoring, submitting, and obtaining approval of Class IIb variations and/or renewals
• Experience supporting new medical device submissions, license renewals, and post-approval variations
• Experience assessing and supporting regulatory submissions associated with manufacturing site or manufacturing process changes
• International regulatory submission experience outside the U.S., including one or more of the following regions:
  • JAPAC/APAC – Singapore, Malaysia, Hong Kong, Vietnam
  • MEAR – South Africa, Botswana and other African markets
  • LATAM – Brazil, Mexico
• Experience preparing and coordinating responses to Health Authority questions related to submissions, renewals, and variations
• Experience reviewing engineering study protocols/reports and validation protocols/reports
• Strong cross-functional communication skills with the ability to work effectively with R&D, Engineering, Manufacturing, Operations, and Regulatory teams

We are seeking an experienced Regulatory Affairs professional to support global medical device regulatory activities, including new device submissions, renewals, variations, manufacturing changes, and lifecycle management.

This role will partner closely with R&D, Operations, Engineering, Manufacturing, and Regulatory Affairs teams to develop and execute regulatory strategies and support continued product approvals across global markets.

Job Description

The Regulatory Affairs Specialist will develop and execute medical device regulatory strategies supporting product development and lifecycle management activities. This individual will manage regulatory content and submission activities with limited supervision and work cross-functionally to support timely global product approvals.

Responsibilities will include preparing and supporting new market applications, renewals, variations, amendments, and other regulatory submissions, as well as managing regulatory activities associated with manufacturing changes for EU Class IIb medical devices.

The Regulatory Affairs Specialist will represent RA Device on product development and lifecycle management teams, providing regulatory guidance and collaborating with R&D, Operations, Engineering, and Manufacturing stakeholders.

Additional responsibilities include reviewing and approving engineering studies, validation protocols and reports, and manufacturing changes, coordinating responses to Health Authority questions, and maintaining compliance with applicable global medical device regulations, including EU MDR 2017/745.

The ideal candidate will have demonstrated success taking international medical device regulatory activities from authoring and submission through Health Authority approval, with the ability to independently manage multiple regulatory priorities.
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