Regulatory Affairs Specialist jobs in Hayward, CA

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

C
Regulatory Affairs Specialist II
  • Confidential
  • Alameda, CA CONTRACTOR
  • Job Title: Regulatory Affairs Specialist II

    Location - 2901 Harbor Bay Parkway, Alameda, CA 94502

    Duration – 12 Months

    Pay rate - $59/hr

    Years of Experience: At least 5 years

    Location: On-Site (5-days a week)

    Experience Background (Any): Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory submission, or APAC-related work under Quality Assurance/Engineering.

    Job Description (Expectation)

    · Responsible for regulatory activities, including product registrations, impact assessment, etc.

    · Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.

    · Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.

    · Plan and execute the given tasks proactively in a timely manner.

    · Report the status to a manager weekly.

    · Keep the training records up to date to do the tasks.

    Other

    · Knowledge of International Standards, such as ISO13485, IEC60601.

    · Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.

    · Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.

    · Ability to manage time and projects.

    · Strict to work 40hrs per week.

    Job Type: Contract

    Pay: $21.00 - $59.00 per hour

    Benefits:

    • Dental insurance
    • Health insurance
    • Paid time off

    Schedule:

    • Evening shift

    Ability to Commute:

    • Alameda, CA 94502 (Required)

    Ability to Relocate:

    • Alameda, CA 94502: Relocate before starting work (Required)

    Work Location: In person

  • 3 Days Ago

I
Senior Regulatory Affairs Specialist
  • iota Biosciences
  • Alameda, CA OTHER
  • iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics. Bioelectronic med...
  • 1 Month Ago

A
Regulatory Affairs Specialist II – Diabetes Care
  • Abbott Laboratories
  • Alameda, CA FULL_TIME
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and ...
  • 20 Days Ago

S
Regulatory Affairs Specialist (Risk Management/Product Registration)
  • Systems Ally
  • Alameda, CA CONTRACTOR
  • Location: On-Site (5-days a week) 100% Onsite Interviews- will do 1 or 2 Teams interviews (depends on the candidate/1st interview) Top experience manager is looking for: Risk management, product manag...
  • 7 Days Ago

A
Regulatory Affairs Specialist – APAC - Diabetes Care (on-site)
  • Abbott
  • Alameda, CA FULL_TIME
  • The Opportunity We are presently hiring for a Regulatory Affairs Specialist, as part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division HQ location in Alameda, C...
  • 18 Days Ago

4
Associate Director, Regulatory Affairs
  • 4D MOLECULAR THERAPEUTICS
  • Emeryville, CA FULL_TIME
  • At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as ...
  • 24 Days Ago

Filters

Clear All

Filter Jobs By Location
  • Filter Jobs by companies
  • More

0 Regulatory Affairs Specialist jobs found in Hayward, CA area

N
Principal Regulatory Affairs Specialist
  • Nevro
  • Redwood City, CA
  • About Nevro Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focu...
  • 3/28/2024 12:00:00 AM

A
Regulatory Affairs Specialist II - Heart Failure
  • Abbott
  • Pleasanton, CA
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
  • 3/28/2024 12:00:00 AM

M
Senior Director/Executive Director, Regulatory Affairs
  • Meet
  • Redwood City, CA
  • Senior Director or Executive Director, Regulatory Affairs (Generalist) Hybrid Role - 3 Days in Menlo Park, CA Meet is pa...
  • 3/28/2024 12:00:00 AM

S
US Regulatory Affairs Specialist
  • Stripe
  • South San Francisco, CA
  • Who we are About Stripe Stripe is a financial infrastructure platform for businesses. Millions of companies - from the w...
  • 3/27/2024 12:00:00 AM

A
Regulatory Affairs Specialist II - APAC - Diabetes Care
  • Abbott
  • Alameda, CA
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
  • 3/26/2024 12:00:00 AM

C
Scientist (NGS)
  • Complete Genomics
  • San Jose, CA
  • Are you a proactive, strategic thinker with hands-on expertise, driven to act, adaptable to changing directions and meth...
  • 3/26/2024 12:00:00 AM

A
Regulatory Affairs Specialist II – Heart Failure
  • Abbott
  • Pleasanton, CA
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
  • 3/25/2024 12:00:00 AM

B
Material Handler - Temp
  • Bio-Rad Laboratories, Inc.
  • San Francisco, CA
  • **Material Handler - Temp** ** Material Handler - Temp** * 2022-27131 * Richmond, California, United States The Material...
  • 3/24/2024 12:00:00 AM

Hayward (/ˈheɪwərd/; formerly Haywards, Haywards Station, and Haywood) is a city located in Alameda County, California in the East Bay subregion of the San Francisco Bay Area. With a 2014 population of 149,392, Hayward is the sixth largest city in the Bay Area and the third largest in Alameda County. Hayward was ranked as the 37th most populous municipality in California. It is included in the San Francisco–Oakland–Fremont Metropolitan Statistical Area by the US Census. It is located primarily between Castro Valley and Union City, and lies at the eastern terminus of the San Mateo–Hayward Bridg...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$92,202 to $123,563
Hayward, California area prices
were up 4.5% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020