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ManpowerGroup Regulatory Specialist II in Alameda, California

Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Lake Forest, IL for a Associate Financial Analyst role to assist their team. This is an on-site role.

Industry: Medical device

Job Title : Regulatory Specialist II

Pay rate: $52-57/hr on W2

Location: Alameda, CA (100% onsite)

Duration: 12 months contract with possible extension

Interviews- will do 1 or 2 Teams interviews (depends on the candidate/1st interview)

Occasional Night call- 4-5 PM, 5-6 PM or 6-7 PM

Team environment- 5 people currently. Very open and collaborative team.

Job Description

Responsible for regulatory activities, including product registrations, impact assessment, etc.

Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.

Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.

Plan and execute the given tasks proactively in a timely manner.

Report the status to a manager weekly. Keep the training records up to date to do the tasks.

List any preferred requirements that would stand out on a resume: understand technical sections (risk management, product change control, biological evaluation)

Years of experience required:

5+ Required education level/certifications: BS, MS Daily tasks/duties and department interactions: prep submissions, regulatory strategy, review change control, other assigned tasks.

Interacting with QA, Labeling, Engineer, PMO. Etc.

Description of work environment/department: Assigned Desk, quiet area but dynamic work, Occasional night calls (after 5PM) with Affiliates.

Preferred interview method (one step or two step/phone or video conference): video interviews- two step interviews

Regardless of education, looking for 5+ years of experience

Medical device experience required.

Internship experience not acceptable.

Needs to be 5+ professional experience.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.

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