Regulatory Affairs Associate II Medical Devices

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).