Government Affairs Director 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 Director 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 Director 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 Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Government Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (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
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
0 Government Affairs Director jobs found in Akron, OH area