More jobs:
Regulatory Affairs Associate II_
Job in
Springfield, Sangamon County, Illinois, 62777, USA
Listed on 2026-09-30
Listing for:
K3-Innovations, Inc.
Full Time
position Listed on 2026-09-30
Job specializations:
-
Healthcare
Healthcare Compliance -
Pharmaceutical
Healthcare Compliance
Job Description & How to Apply Below
Contract: Through August 2027
Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or related field
We are seeking an experienced Regulatory Affairs Associate II to support regulatory activities and product approvals within a complex, matrixed environment.
Responsibilities- Prepare regulatory submissions, including new applications, amendments, renewals, annual reports, supplements, and variations
- Respond to regulatory information requests and support regulatory decision-making
- Analyze information impacting regulatory strategies and submissions
- Manage preparation for agency meetings and pre-meeting submissions
- Manage products and change controls in accordance with regulations, company policies, and procedures
- Handle government interactions related to products requiring regulatory approval
- Author and submit PMA supplements
, including 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports - Review and approve engineering and validation study protocols and reports
- Review and approve manufacturing changes for Class III implantable medical devices
- Work closely with internal and external partners to support delivery of products to patients
- Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or related discipline
- Approximately 6 years of pharmaceutical or industry-related experience
- 3–5 years of experience in quality systems or cross-functional project management
- Experience working in a complex, matrixed organization
- Strong written and verbal communication skills
- Approximately 6 years of pharmaceutical experience, including 5 years in Regulatory Affairs or 5 years in Discovery, R&D, or Manufacturing
- Recent experience with Class III implantable medical devices
- Proven experience authoring, submitting, and obtaining approval for Class III implantable PMA supplements
- Knowledge of FDA PMA guidance documents and CFR regulations
- Experience with engineering/validation protocols and reports
If you have strong regulatory affairs experience and a background in PMA submissions, Class III medical devices, FDA regulations, and cross-functional project management
, we’d like to hear from you!
Position Requirements
10+ Years
work experience
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