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Regulatory Affairs Associate (70315)

Company: Rangam Consultants, Inc.
Location: Sunnyvale
Posted on: June 15, 2019

Job Description:

Responsibilities This position interacts with multiple departments, as appropriate, involved in regulatory submissions, the design of IVD medical devices and software. The position, under the supervision of the manager, manages technical file changes, reviews labeling changes for completeness and suitability for submission. Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA. Reviews engineering change requests to assess impact to regulatory submissions. Responsible for writing import authorization memos to release ship flags to international countries. Assure the regulations and laws regarding 510(k) and PMA submissions meet compliance. Assure Technical and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment. Must have the following: Need to be able to organize and prioritize tasks and work independently of a manager. Ability to adapt to a fast-paced work environment. Ability to meet deadlines. Strong attention to detail. Work with all team members to accomplish tasks and be able to clearly communicate with the team. Capable of assessing product changes and determine regulatory impact. Review technical documentation with a critical eye for typos, grammatical errors, etc. Impact of Actions / Decisions -Within functional area: This position is expected to review critical documents and handle routine assignments with little input from the manager. With more complex tasks/submissions, work with the manager to accomplish goals/tasks. Outside functional area: Work with various functions to resolve any deficiencies. Work experience: At least three to five years of work experience. Experience in post-market regulatory tasks. Strong knowledge of change control process. Understanding of scientific disciplines required. Understanding of FDA regulations governing 510(k)s, PMAs, Software cybersecurity requirements, submission processes, and submission content. 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.

Keywords: Rangam Consultants, Inc., Sunnyvale , Regulatory Affairs Associate (70315), Other , Sunnyvale, California

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