Regulatory Affairs Associate II

Regulatory Affairs Associate II

Location: Irvine, California

Category: Regulatory Affairs

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

Target PR Range: 33-43/hr DOE

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.

• Experience Level = 3-5 Years

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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