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Regulatory Affairs Associate II Medical Devices
Contract: North Chicago, Illinois, US
Salary Range: 35.00 - 40.00 | Per Hour
Job Code: 371912
End Date: 2026-10-26
Days Left: 28 days, 3 hours left
Hi there, I'm Siddhi, Talent Expert with Collabera LLC. Hope this message finds you well! We're actively hiring for top performers, and I think you could be a great fit.
Why apply now? Positions are filling fast, and we're hiring immediately. If this resonates with you, I'd love to chat about how your background aligns with this opportunity. Let's explore if it's the right next move for you.
Ready to connect?
Email: siddhi.kadakia@collabera.com or Phone: (847)-440-1112
Why apply now? Positions are filling fast, and we're hiring immediately. If this resonates with you, I'd love to chat about how your background aligns with this opportunity. Let's explore if it's the right next move for you.
Ready to connect?
Email: siddhi.kadakia@collabera.com or Phone: (847)-440-1112
Position Details:
Position: Regulatory Affairs Associate II – Medical Devices
Length of Initial Contract: 12 Months Contract
Location/Site: North Chicago, IL 60064
Onsite: Hybrid
Pay Range: $35.00 to $40.00 per hour
Position: Regulatory Affairs Associate II – Medical Devices
Length of Initial Contract: 12 Months Contract
Location/Site: North Chicago, IL 60064
Onsite: Hybrid
Pay Range: $35.00 to $40.00 per hour
- Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
- Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management
- Preferred Experience: 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing.
Top Skills Needed for each role:
- Experience working in a complex and matrix environment
- Strong oral and written communication skills
- 3-5 years in quality systems or cross-functional project management
- Regulatory affairs experience
- Experience with Class III implantable medical devices
Job Description:
This contractor will work with internal and external partners in order to deliver products to patients. Job deliverables will include:
- Prepare regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
- Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
- Manages preparation for agency meetings and manages content of pre-meeting submissions.
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Manages products and change control with an understanding of regulations and company policies and procedures.
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Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices.
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May require an advanced degree and 3 to 5 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks.
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May lead and direct the work of others.
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A wide degree of creativity and latitude is expected.
Experience Level = 3-5 Years
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).
Job Requirement
- Regulatory Affairs
- Medical Devices
- Class III Medical Devices
- Implantable Medical Devices
- FDA
- PMA
- PMA Supplements
- 30-Day Notice
- Real-Time Review
- 180-Day Supplement
- Annual Reports
- Regulatory Submissions
- FDA PMA Guidance
- CFR Regulations
- Regulatory Strategy
- Change Control
- Quality Systems
- Cross-Functional Project Management
- Agency Meetings
- Regulatory Compliance
- Manufacturing Changes
- Validation Studies
- Engineering Studies
- Pharmaceutical Industry
- Medical Device Regulatory Affairs
Reach Out to a Recruiter
- Recruiter
- Phone
- Siddhi Kadakia
- siddhi.kadakia@collabera.com
Apply Now
Apply Now
