Regulatory Affairs Associate II – Medical Devices
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.
- Manages products and change control with an understanding of regulations and company policies and procedures.
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.
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.
May lead and direct the work of others.
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).
