Government Affairs Manager jobs in Ventura, CA

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)

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Regulatory Affairs Associate
  • Actalent
  • Ventura, CA OTHER
  • **Fully remote job opportunity**

    Description:

    • Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, AU, Japan, MEA etc.)
    • Independently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device submissions including US 510(k), Health Canada licenses, AU technical files, Japan, MEA and other countries as well as for human tissue bank products for US FDA and various States.
    • Represent Regulatory Affairs on assigned project teams through all phases of product development, provide Regulatory Strategy and assess regulatory impact of changes on existing products
    • Coordinate and prepare document packages for regulatory submissions to the US, EU, AU, and Canada [510(k) Pre-Market Notifications, Product Reports/Supplements, Tech Files, Health Canada].
    • Responsible in the preparation and compilation of domestic and international product registration submissions. This includes, but is not limited to Pre-Market Notifications, 510ks, AU technical files and international dossiers (Canada, Saudi Arabia, Japan, Egypt, Indonesia etc.), US Tissue Bank licenses, and Canada CTO licenses.
    • Represent Regulatory Affairs on change controls and provide regulatory assessment.
    • Review and approve marketing communication materials
    • Provide guidance on global compliance, such as GMP and product registrations, clinical evaluations in accordance with US FDA, AU TGA, Canadian CMDCAS, MDSAP and ISO 13485,etc.
    • Monitor regulatory and legislative environment and assess impact of new regulations and works with project teams and responsible leaders to provide compliance/product registration requirements and potential effects for design changes and manufacturing process changes
    • Provide information and materials for Certificate to Foreign Governments (CFG), and medical device listings for FDA.
    • Participate in the planning, conduct, and reporting for external audits (FDA, Notified Body, international regulators, etc.) as requested.
    • Participate, as assigned, as a CAPA owner, team member, or “task” owner.
    • Work with project teams and responsible leaders to provide compliance/product registration requirements and potential effects for design changes and manufacturing process changes.
    • Direct communication with regulatory authorities regarding company’s regulatory filings.
    • Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.
    • Create and update departmental standard operating procedures (SOPs).

    Additional Skills & Qualifications:

    • Experience with FDA, Health Canada and international regulators is strongly preferred.
    • Advanced degree and/or Regulatory Affairs Certification (RAC) preferred.
    • Experience in supporting international registrations.
    • Expert knowledge of US and international medical devices regulations, guidelines, and policies.

    Experience Level:

    Expert Level

    About Actalent

    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.

    Diversity, Equity & Inclusion

    At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

    • Hiring diverse talent
    • Maintaining an inclusive environment through persistent self-reflection
    • Building a culture of care, engagement, and recognition with clear outcomes
    • Ensuring growth opportunities for our people

    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.

  • Just Posted

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Associate Regulatory Affairs
  • Aditi Consulting
  • Thousand Oaks, CA FULL_TIME
  • Summary : The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC...
  • Just Posted

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Associate Regulatory Affairs-CMC
  • Donatech Corporation
  • Thousand Oaks, CA FULL_TIME
  • Position would require the candidate to be a W2 employee of Donatech US Citizenship / Permanent Resident Required FULLY REMOTE The Associate Regulatory Affairs (CMC) role is an entry level regulatory ...
  • Just Posted

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Regulatory Affairs Associate
  • Actalent
  • Newbury, CA FULL_TIME
  • JOB SUMMARY: Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, AU, Japan, MEA etc.) ESSENTIAL DUTIES:Independently plan, prepare, coordi...
  • 2 Days Ago

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Sr. Regulatory Affairs Associate
  • Actalent
  • Newbury, CA FULL_TIME
  • JOB SUMMARY: Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, AU, Japan, MEA etc.) ESSENTIAL DUTIES:Independently plan, prepare, coordi...
  • 2 Days Ago

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Associate Regulatory Affairs-CMC
  • Ampcus, Inc
  • Thousand Oaks, CA FULL_TIME
  • What we are looking for: Desire to learn Regulatory Affairs CMC and global submission strategy Strong organizational skills with attention to detail Proficient time management skills and ability prior...
  • 12 Days Ago

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0 Government Affairs Manager jobs found in Ventura, CA area

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Licensed Vocational Nurse (All Vacancies Including FT PT and PRN)
  • Department of Veterans Affairs
  • Ventura, CA
  • Summary This is an open continuous announcement. We accept applications for these occupations on an ongoing basis; quali...
  • 3/28/2024 12:00:00 AM

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Sr. Regulatory Affairs Associate
  • Actalent
  • Thousand Oaks, CA
  • MEDICAL DEVICE/ PHARMACEUTICAL COMPANY IN THOUSAND OACKS IS LOOKING FOR A SR LEVEL REGULATORY AFFAIRS PROFESSIONAL TO JO...
  • 3/28/2024 12:00:00 AM

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Nursing Assistant (All Vacancies Including FT PT and PRN)
  • Department of Veterans Affairs
  • Santa Barbara, CA
  • Summary This is an open continuous announcement. We accept applications for these occupations on an ongoing basis; quali...
  • 3/28/2024 12:00:00 AM

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Assistant Manager - Oxnard Outlet
  • Design Within Reach
  • Oxnard, CA
  • **Assistant Manager - Oxnard Outlet** at Design Within Reach Oxnard, California The Outlet Assistant Manager will partne...
  • 3/27/2024 12:00:00 AM

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Supervisory Public Affairs Specialist (Internal/External Communications Mgr) MSP (12-month roster)
  • Department Of The Treasury
  • Camarillo, CA
  • Duties WHAT IS THE Tax Exempt/Government EntitiesDIVISION? A description of the business units can be found at: https://...
  • 3/26/2024 12:00:00 AM

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Sales Manager - Buick/GMC
  • Andersonholdings
  • Thousand Oaks, CA
  • At AndersonAutos, we are committed to an environment where the customer is always treated with respect and dignity. Our ...
  • 3/26/2024 12:00:00 AM

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Executive Director, Global Safety Head, Obesity
  • Amgen
  • Thousand Oaks, CA
  • **HOW MIGHT YOU DEFY IMAGINATION?** At Amgen, every challenge is an opportunity. And every opportunity brings the potent...
  • 3/25/2024 12:00:00 AM

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Academic Specialist, Global Programs
  • University of California
  • Santa Barbara, CA
  • Working Title: Academic Specialist, Global Programs Payroll Title:?Student Academic Advisor 3 Job Code:?004545 Job Open ...
  • 3/24/2024 12:00:00 AM

Ventura is located northwest of Los Angeles on the California coast. The western portion of the city stretches north along the Ventura River and is characterized by a narrow valley with steeply sloped areas along both sides. The steep slopes of the Ventura foothills abut the northern portion of the community. Much of the eastern portion is on a relatively flat alluvial coastal plain lying along the western edge of the Oxnard Plain. The Santa Clara River forms the city's southerly boundary with the city limits reaching up to the beginning of the Santa Clara River Valley at the historic communit...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Government Affairs Manager jobs
$141,235 to $207,426
Ventura, California area prices
were up 2.5% from a year ago

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