Government Affairs Manager implements strategic plans and oversees engagement objectives to develop and maintain productive relations with all levels of government authorities that will support and enhance the businesses' goals. Manages teams that build relationships and liaise with government entities(federal, state, provincial, or local) that regulate or influence business activities. Being a Government Affairs Manager performs ongoing monitoring and analysis of proposed legislation, emerging issues, and trends to determine the potential impact on the organization. Collaborates with industry groups and organizations with complementary objectives to achieve objectives. Additionally, Government Affairs Manager creates communication vehicles and delivers messaging to inform and support business leaders. Requires a bachelor's degree in public policy, public administration, business or equivalent. Typically reports to a director. The Government Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Government Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Description:
- Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance.
- Assist in maintaining the Quality Management System to ensure domestic and international standards are met.
- Support the development of new and revised products through the analysis of applicable regulations and the creation and implementation of the appropriate regulatory strategies.
- Register new products with the appropriate agencies and organizations and maintain the registrations of existing products according to the applicable regulatory strategies.
- Provide guidance to the Engineering staff on the creation and maintenance of Design History Files (DHF), Device Master Records (DMR) and Technical Files.
- Interface with cross-functional teams on large and small projects to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.
Skills:
Regulatory affairs, Regulatory, Medical device, Fda, Regulatory submission, Regulatory documents, Regulatory compliance, Iso 13485, Gmp, eu mdr, 21cfr 820, Labelling, Quality assurance, Compliance
Additional Skills & Qualifications:
- Bachelor’s degree in a science, mathematics, engineering or other technology field is preferred.
- 3-5 years of progressive experience in regulatory affairs required
- Prior knowledge of 21CFR 820, ISO13485, MDR QMS requirements required
- Experience with EU MDR Technical Documentation preferre
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0 Government Affairs Manager jobs found in Akron, OH area