Regulatory Affairs Associate II - Medical Device global submissions, license renewals, and variations

Regulatory Affairs Associate II - Medical Device global submissions, license renewals, and variations

Irvine, CA – Hybrid (Tues, Wed, Thurs onsite)

Currently goes through end of August 2027

Hourly Rate: $42-45/hr

This Regulatory Affairs Device role will be based in Irvine, CA and works with internal and external partners in order to deliver products to patients.

Responsibilities

• Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision.
• Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations.
• Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.
• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class IIb (EU) medical devices.

Qualifications

• Experience supporting new device submissions, license renewals and variations (based on manufacturing site proposed changes) in countries outside of US, such as JAPAC (Singapore, Malaysia, Hong Kong, Vietnam), MEAR (S Africa, Botswana, and other African countries), LATAM (Brazil, Mexico).
• In addition, there should be experience in responding to health authority questions satisfactorily due to submissions/renewals/variations.
• May require an advanced degree and 3 to 5 years of direct experience in the field.
• Recent experience with Class IIb (EU) medical devices;
• Proven successful track record of authoring/submission/approval of Class IIb variations/renewals; knowledge of EU MDR 2017/745 regulation.
• Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. A wide degree of creativity and latitude is expected.

People are our business worldwide

Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.