Regulatory affairs associate ii - # 26-24171

Duration: 11+ Months

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.

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