Regulatory Affairs Associate II - # 26-24171

Us Tech Solutions; Irvine (CA); On-site; USD 100,000 - 170,000; Full time

Job summary

US Tech Solutions, Irvine, CA, seeks a Regulatory Affairs professional to lead device regulatory strategies and submissions across global markets. You will collaborate with RA, R&D, and Operations to ensure timely approvals and lifecycle management for Class IIb devices.

Responsibilities include preparing submissions (INDs/CTAs), managing government interactions, and reviewing engineering/validation protocols, with focus on EU MDR 2017/745 requirements and cross-regional variations.

Qualifications

• 3–5 years of direct experience in device regulatory affairs.
• Experience supporting submissions and renewals outside US regions (JAPAC, MEAR, LATAM).
• Experience with Class IIb EU medical devices and EU MDR 2017/745.

Responsibilities

• Prepare device regulatory strategies and content for submissions (INDs/CTAs, amendments, new market applications).
• Engage RA, Operations, and R&D teams to align regulatory plans.
• File applications and manage government interactions for regulatory approvals.
• Review engineering and validation study protocols and approve manufacturing changes for Class IIb EU devices.

Skills

Regulatory strategy

Regulatory submissions

EU MDR knowledge

Lifecycle management

Cross-functional coordination

Education

Advanced degree

Job description

Duration: 11+ Months

• 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.

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 (BrClientil, 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.
• Experience Level = 3-5 Years

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.