Regulatory Affairs Associate II

job summary:
Advance your career as a Regulatory Affairs Associate II with a Top-Tier Global Pharma Leader in North Chicago, IL. This hybrid role offers an exciting opportunity to work directly with internal and external partners to deliver life-changing medical products to patients while managing key regulatory submissions and filings.

location: North Chicago, Illinois
job type: Contract
salary: $39.00 - 42.18 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Author and submit PMA supplements, including 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
• Prepare, analyze, and manage regulatory submissions, renewals, amendments, and variations under limited supervision.
• Review and approve manufacturing changes, engineering study protocols/reports, and validation study protocols/reports for Class III implantable medical devices.
• Handle government interactions and manage preparation and content for regulatory agency meetings.
• Manage product change controls while ensuring strict alignment with FDA guidance, CFR regulations, and company policies.

 
qualifications:

Required:

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or a related scientific field.
• 3-5 years of direct regulatory affairs experience, specifically with Class III implantable medical devices.
• Proven track record of successful authoring, submission, and approval of Class III PMA supplements.
• Strong working knowledge of FDA PMA guidance documents and CFR regulations.
• 6 years of total biotech or pharmaceutical industry experience.

Preferred:

• Experience working effectively within complex, matrixed organizational environments.

#LI-MH1

skills: Regulatory Affairs Operations


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.