Regulatory Affairs Specialist jobs in Houston, 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)

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Regulatory Affairs Specialist
  • Actalent
  • Houston, TX OTHER
  • Description: 100% REMOTE

    The Regulatory Affairs Specialist is responsible for implementing global product Regulatory strategies and processes focused on ensuring compliant, timely, and cost-effective submissions to get needed licenses, registrations, and listings for medical devices and drugs.

    Key Responsibilities:

    • Lead timely execution of Regulatory submission activities required to secure global market clearances, registrations and licenses for medical device and drug products

    • Assist with providing leadership to global business in the preparation of regulatory submission documents and activities required to secure global licenses, registrations and listings in a timely and cost-effective manner

    • Assist with the development of effective long and short-term Regulatory product strategies by closely working with global Sales/Marketing and Product Development teams on pipeline medical device and drug international registrations

    • Ensure accuracy of Declaration of Conformity for EU in conjunction with Authorized Representative and provide support for medical device and drug classification in global markets

    • Review product and labeling/claims changes to maintain regulatory compliance

    • Maintain regulatory records by updating corporate databases, recording and filing appropriate regulatory registrations and submissions

    • Ensure product labeling and claims are accurate, substantiated, documented, and compliant with applicable regulations

    • Oversee and maintain site establishment registrations and certifications

    • Monitor domestic and international regulatory development changes that may potentially impact the company’s products and operations, and provide proactive interpretative analysis of regulations, directives and guidance for required actions

    • Provide education and training on regulations to company employees, as needed

    • Investigate and report to global regulatory authorities (as required) product complaints

    Skills & Qualifications:

    At a minimum, completion of a Bachelor's (e.g. Life/Physical Science, Engineering, Business, etc.) is required. Additional training in regulatory affairs, quality assurance, project management, risk management, etc. is strongly preferred. Advance degree is also strongly preferred.

    • An experienced regulatory professional with 5 years of medical devices and associated regulatory experience

    • 5 years of experience developing and successfully defending complex regulatory submissions for medical devices and drugs

    • Experience supporting Class III PPE products

    • Proven experience building effective relationships with the FDA and other international regulatory bodies including the EU and Health Canada

    • Experience with submitting Adverse Events/Vigilance reports to applicable global regulatory bodies

    • Strong knowledge of global country-specific regulations required for registering and marketing products for sale in applicable countries

    • Understanding of FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standards

    • Must have excellent written and spoken English

    • Excellent communication and organizational skills

    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.

  • 6 Days Ago

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Regulatory Affairs Specialist
  • Empower Pharmacy
  • Houston, TX FULL_TIME
  • Position Summary: The Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements related to the development, manufacturing, and distribution of our prod...
  • 7 Days Ago

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Sr Regulatory Affairs Specialist
  • honeywell2-pilot
  • Houston, TX FULL_TIME
  • The Sr Product Stewardship Specialist, provides expert product stewardship guidance and leadership to businesses and technology developers regarding compliance with global programs under US FDA, EU EM...
  • 1 Month Ago

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Regulatory Affairs Specialist - Medicaid
  • BlueSprig
  • Houston, TX OTHER
  • Blue Sprig Pediatrics, Inc is committed to advancing the mission of changing the world for children withautism and delivering services to families impacted by Autism Spectrum Disorder. As a leader in ...
  • 1 Month Ago

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Regulatory Affairs Specialist - Medacaid
  • Trumpet Behavioral Health
  • Houston, TX OTHER
  • Overview Blue Sprig Pediatrics, Inc is committed to advancing the mission of changing the world for children withautism and delivering services to families impacted by Autism Spectrum Disorder. As a l...
  • 2 Months Ago

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Regulatory Affairs Specialist - Medacaid
  • BlueSprig
  • Houston, TX OTHER
  • Blue Sprig Pediatrics, Inc is committed to advancing the mission of changing the world for children withautism and delivering services to families impacted by Autism Spectrum Disorder. As a leader in ...
  • 2 Months Ago

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0 Regulatory Affairs Specialist jobs found in Houston, TX area

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Entry Level Virtual Sales Consultant: Financial Services & Insurance Sector
  • Bein Financial Group
  • Houston, TX
  • We are looking for a few individuals that are result-oriented individual with a passion for sales and a keen interest in...
  • 3/29/2024 12:00:00 AM

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Associate Roving Personal Banker- Southeast Gulf Coast District
  • WELLS FARGO BANK
  • La Porte, TX
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/29/2024 12:00:00 AM

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Associate Roving Personal Banker- Southeast Gulf Coast District
  • WELLS FARGO BANK
  • Houston, TX
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/29/2024 12:00:00 AM

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Director of Finance
  • Kidney Cancer Association
  • Houston, TX
  • Full-Time / Exempt Salary: $157,500 Location: Houston, TX Travel Expectation: Minimal Report to: President and CEO The K...
  • 3/29/2024 12:00:00 AM

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Branch Manager Jetero
  • WELLS FARGO BANK
  • Houston, TX
  • Wells Fargo is seeking a Branch Manager (SAFE) for National Branch Network as part of the Consumer, Small and Business B...
  • 3/28/2024 12:00:00 AM

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Senior Regulatory and Compliance Specialist - Orthopedic Research
  • UT Health Science Center at Houston
  • Houston, TX
  • What we do here changes the world. UTHealth Houston is Texas' resource for healthcare education, innovation, scientific ...
  • 3/27/2024 12:00:00 AM

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Civil/Structural Engineer
  • Exponent, Inc.
  • Houston, TX
  • About Exponent Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of exp...
  • 3/26/2024 12:00:00 AM

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Research Compliance Specialist- IRB
  • Houston Journal of Health Law & Policy
  • Houston, TX
  • Description Under the direction of the Director of the Office of Research Policies, Compliance and Committees, coordinat...
  • 3/25/2024 12:00:00 AM

Houston is located 165 miles (266 km) east of Austin, 88 miles (142 km) west of the Louisiana border, and 250 miles (400 km) south of Dallas. The city has a total area of 627 square miles (1,620 km2); this comprises 599.59 square miles (1,552.9 km2) of land and 22.3 square miles (58 km2) covered by water. The Piney Woods are north of Houston. Most of Houston is located on the gulf coastal plain, and its vegetation is classified as temperate grassland and forest. Much of the city was built on forested land, marshes, swamp, or prairie and are all still visible in surrounding areas.[citation need...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$77,024 to $103,223
Houston, Texas area prices
were up 2.3% 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