Regulatory Affairs Associate
North Chicago, Illinois, United States
Job Description
Responsibilities:
Required Experience:
Preferred Experience:
Required Education:
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- uthoring 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
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
- Experience working in a complex and matrix environment
- Strong oral and written communication skills
- This contractor will work with internal and external partners in order to deliver products to patients.
- Prepare regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
- nalyzes 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.
Required Education:
- Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
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Career Focus: Regulatory/Compliance
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