Regulatory Affairs Specialist jobs in Austin, TX
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)
Recently Added Regulatory Affairs Specialist jobs
Sr. Regulatory Affairs Specialist
- Hired by Matrix
-
Austin, TX
FULL_TIME
-
Do you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you!
Working with some of the US’ premier companies, we excel at connecting candidates with positive cultures and dynamic teams. We even go the extra mile with our signature Consultant Appreciation Program (CAP) to help them in their future job searches.
Hired by Matrix has provided talent solutions to enhance organizations’ team capacities for over three decades. As a full-service search firm, we partner with companies across industries, including Financial Services, Fintech, Consumer Goods and Services, Security and Logistics, Pharmaceutical / Biotech, Technology, Automotive, Engineering, and Healthcare.
At-a-Glance:
Are you ready to build your career by joining a multi-national medtech company? If so, our client is hiring a Sr. Regulatory Affairs Specialist!
What You’ll Do:- Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements.
- Identifies, analyzes and implements country specific requirements necessary for product related submissions.
- Recommend strategies for earliest possible approvals for marketing applications.
- Performs regulatory projects or acts as a member of the project steering group.
- Submits required documentation/information to local authorities.
- Initiates and escalates necessary activities if deviations are identified.
- Ensures creation of adequate documentation for audits/inspections.
- Performs training within the organization in country specific regulatory requirements, if applicable.
- Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance.
- Performs review of promotional material for regulatory compliance according to country specific requirements.
- 5 to 8 years’ experience.
- Product Registration Experience:
- Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files.
- Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
- Knowledge of regulatory guidance documents (FDA, Health Canada, and EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
- Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and ISO 10993-1 as evidenced by coursework or submissions that required use of each standard.
- Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
- Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.
Get in Touch:
We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Rishaw at 646-688-5839 to learn more.
Who We Are:
Since 1986, Hired by Matrix, Inc. has improved our candidates' lives with exciting job opportunities that provide outstanding career advancement. Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days, and a 401k option with a company match after one year. Hired by Matrix is an Equal Opportunity Employer and proud to be certified as both a Woman-Owned Business Enterprise and a Woman-Owned Small Business.
Connect with us on LinkedIn today and learn more about how HbM can change your career: https://www.linkedin.com/company/hired-by-matrix-inc/
Check out our Career Center: https://www.hiredbymatrix.com/find-work/open-positions/
#HbMG266About the Company:
Hired by Matrix
We believe in putting people together for the right reasons. Getting you a great job that makes you feel fulfilled in your career. Finding the perfect candidate to help you achieve business success. Whether you are looking for the best candidate for your company or searching for your next career move, we are dedicated to making sure you thrive. We take your needs personally and have a variety of services to ensure you reach your goals. We listen to the needs of our clients and candidates and then thoughtfully match the right person with the right job. When people come together doing what they love success is guaranteed and partnerships last.Company Size:
100 to 499 employeesIndustry:
Staffing/Employment AgenciesFounded:
0Website:
http://www.hiredbymatrix.com
- 1 Month Ago
Regulatory Affairs Associate
- Percepto
-
Austin, TX
FULL_TIME
- About The Position Percepto is the leading provider of autonomous inspection and monitoring solutions, harnessing robotics, including its very own market-leading industrial drone-in-a-box solution. Ou...
- 18 Days Ago
Director Regulatory Affairs
- Hunt
-
Austin, TX
FULL_TIME
- Company Description: Hunt Energy Network (HEN), a subsidiary of Hunt Consolidated, provides world-class solutions for clean energy assets in ERCOT by developing and managing distributed energy resourc...
- 2 Months Ago
Director Regulatory Affairs
- Hunt Consolidated
-
Austin, TX
FULL_TIME
- Company Description: Hunt Energy Network (HEN), a subsidiary of Hunt Consolidated, provides world-class solutions for clean energy assets in ERCOT by developing and managing distributed energy resourc...
- 2 Months Ago
TDHCA - Inspection Specialist
- TEXAS DEPT OF HOUSING AND COMMUNITY AFFAIRS
-
Austin, TX
FULL_TIME
- TDHCA - Inspection Specialist (00041011) Organization: TEXAS DEPT OF HOUSING AND COMMUNITY AFFAIRS Primary Location: Texas-Austin Work Locations: TDHCA physical address 221 East 11th Street Austin 787...
- 22 Days Ago
Regulatory Specialist
- Omega 365
-
Georgetown, TX
FULL_TIME
- Duties and Responsibilities: Support and ensure the continuing classification and regulatory compliance of the Guyana Fleet & Operations in relation to all required permits, licenses, authorizations, ...
- 1 Month Ago
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0 Regulatory Affairs Specialist jobs found in Austin, TX area
Lead Accountant Financial Reporting
- BGSF
-
Austin, TX
- BGSF is seeking a Lead Accountant Financial Reporting to join our banking client's growing accounting team in Northwest ...
- 4/15/2024 12:00:00 AM
DPS - THP - Field Secretary - 0152
- CAPPS
-
Austin, TX
- Job Description PLEASE NOTE:All applications must contain complete job histories, which includes job title, dates of emp...
- 4/15/2024 12:00:00 AM
Inventory Specialist
- WALGREENS
-
Austin, TX
- Responsible for executing, monitoring, and training inventory best practices and standard operating procedures for the e...
- 4/15/2024 12:00:00 AM
Assistant Chief Nurse Officer
- Ascension
-
Austin, TX
- Details Ascension Texas is looking to hire an Assistant Chief Nursing Officer to join our team at Dell Seton Medical Cen...
- 4/15/2024 12:00:00 AM
Entry Level Virtual Sales Consultant: Financial Services & Insurance Sector
- Bein Financial Group
-
Austin, TX
- We are looking for a few individuals that are result-oriented individual with a passion for sales and a keen interest in...
- 4/13/2024 12:00:00 AM
Associate Project Manager - Due Diligence (Data Center)
- Olsson Associates
-
Austin, TX
- We are seeking a highly skilled and experienced Due Diligence Associate Project Manager to join our team. The ideal cand...
- 4/13/2024 12:00:00 AM
Senior Manager, Environmental Compliance
- Entegris
-
Round Rock, TX
- Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees ...
- 4/11/2024 12:00:00 AM
Regulatory Affairs Specialist II – Diabetes Care
- Abbott Laboratories
-
Austin, TX
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
- 3/27/2024 12:00:00 AM
About Austin, Texas
Austin is the capital of the U.S. state of Texas and the seat of Travis County, with portions extending into Hays and Williamson counties. It is the 11th-most populous city in the United States and the 4th-most populous city in Texas. It is also the fastest growing large city in the United States, the second most populous state capital after Phoenix, Arizona, and the southernmost state capital in the contiguous United States. As of the U.S. Census Bureau's July 1, 2017 estimate, Austin had a population of 950,715 up from 790,491 at the 2010 census. The city is the cultural and economic center ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$75,195 to $100,773
Austin, Texas area prices
were up 1.2% from a year ago
were up 1.2% from a year ago
What does a Regulatory Affairs Specialist do?
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