Job Description
Title: Regulatory Affairs Specialist
Duration: 12 Months with possible extension
Location: Abbott Park, IL or Columbus, OH
POSITION DESCRIPTION:
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 5-8 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. Typically reports to a manager or head of a unit/department.
Employment Type: Contractor
Salary: $ 25.00 27.00 Per Hour
Job Tags
Hourly pay, Contract work, For contractors,
Similar Jobs
SeekTeachers
Description Teach in Al Ain - Immediate Start | Teach for Charter Schools | Teach Abroad - Immediate... ...their first language and so if you have experience dealing with ESL students this will be beneficial for your application. Requirements...
Redwood Trust, Inc.
...Experience, Skills, & Competencies ~ Bachelor's degree in Business, Finance, Accounting or related field ~3 - 5 years of industry... ...planning, financial modeling, and decision analytics (e.g. FP&A, corporate finance, investment banking, private equity)~ Strong computer...
Forestown
..., through its U.S.-based subsidiary Contemporary Amperex Technology Kentucky, LLC (CATK), is seeking a dedicated and experienced EHS Manager to join our North American team. This is a full-time and salary-exempted position. In this role, you will be responsible for and...
Thermo Fisher Scientific
...Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to...
Ashburn Village Inn
...OUR SERVERS WILL MAKE $20/HR WITH TIPS OR WE WILL PAY THE DIFFERENCE DURING THE BI-WEEKLY PAYROLL!! Main Responsibilities of a Waiter/Waitress: Taking orders and delivering food and beverages. Helping guests with menu recommendations. Providing exceptional...