Regulatory Compliance Professional

6 days ago


San Diego, California, United States Abbott Laboratories Full time
About Abbott

Abbott is a leading global healthcare company that focuses on delivering innovative solutions to improve people's lives. Our diverse portfolio of products and services includes diagnostics, medical devices, nutritionals, and branded generic medicines.

Job Overview

This position offers an exciting opportunity to join our team as a Regulatory Affairs Specialist II in the Toxicology business unit. Based in San Diego, CA or Pomona, CA, you will be responsible for reviewing and approving labeling and advertising/promotional materials, ensuring compliance with US, EU, and international regulations and standards.

Key Responsibilities
  1. Provide regulatory support for diagnostic product development and commercial products, ensuring adherence to relevant regulations and standards.
  2. Review and approve labeling, advertising, and promotional materials, and manage translations for country registrations.
  3. Assist in developing regulatory strategies for new and modified products to achieve clearance/approval.
  4. Conduct research on scientific and regulatory information to develop labeling requirements and review verification/validation and risk management reports for accuracy.
  5. Evaluate product, manufacturing, and labeling changes for regulatory impact and compliance.
  6. Develop internal procedures and tools, and conduct informational or training sessions for stakeholders.
  7. Maintain department files and stay informed about global regulatory developments.
Requirements
  • Bachelor's degree (BS/BA) in any biological science or technical degree.
  • 2-5 years experience in Regulatory Affairs with 1-3 years of progressively responsible positions.
Preferred Qualifications
  • 1-3 years in an IVD or medical device manufacturing environment.
  • Good knowledge of federal regulations.
  • Good knowledge of product labeling and related requirements.
  • Good knowledge of quality systems in a regulated manufacturing environment.
  • Proficient with Microsoft Office, including Word, Excel, PowerPoint, and Visio.
What We Offer

We provide a competitive salary range of $65,900.00 – $131,900.00, depending on location and experience. Additionally, we offer a comprehensive benefits package, including free medical coverage via the Health Investment Plan (HIP) PPO, an excellent retirement savings plan with high employer contribution, tuition reimbursement, and education benefits.



  • San Diego, California, United States Cypress HCM Full time

    Job Title: Regulatory Affairs SpecialistJob Summary: Cypress HCM is seeking a dedicated Regulatory Affairs Specialist to coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies.Key Responsibilities:Submission Coordination: Coordinate the...


  • San Diego, California, United States Lifelancer Full time

    Company OverviewBecton, Dickinson and Company is a leading global medical technology company that develops innovative solutions to help healthcare professionals improve patient outcomes. Our purpose is to advance the world of health by delivering meaningful innovations that bring value to our customers, patients, and communities.Salary RangeWe offer a highly...


  • San Diego, California, United States Independent Financial Group Full time

    Independent Financial Group (IFG) is a leading independent broker-dealer seeking a seasoned Risk Management Specialist, Regulatory Compliance to join their team.About IFGFounded in 2003, IFG provides business solutions supporting over 532 independent financial professionals across the country. With a strong presence in San Diego, IFG has received numerous...

  • Compliance Specialist

    3 weeks ago


    San Diego, California, United States AllSTEM Connections Full time

    At AllSTEM Connections, we are committed to fostering a culture of compliance and ensuring the highest standards in our procurement practices.Job OverviewWe are seeking a highly skilled Compliance Specialist with expertise in government procurement regulations, subcontract management, price/cost analysis, and export controls. This is an exciting opportunity...


  • San Diego, California, United States Ajinomoto Bio-Pharma Services Full time

    We are looking for a highly skilled Sr Data Integrity Specialist II to join our QA/Compliance team in San Diego, CA. This is a full-time opportunity with a competitive salary range of $95,646.15 - $135,378.About the RoleThe successful candidate will have a strong background in data integrity, including a thorough understanding of existing and emerging...


  • San Diego, California, United States California Coast Credit Union Full time

    About California Coast Credit UnionWe are a member-owned, not-for-profit financial cooperative dedicated to providing exceptional financial services and products to our members. Our mission is to help our members achieve their financial goals while promoting financial education and stability in our community.Estimated Salary Range: $90,560 - $113,200 per...


  • San Diego, California, United States Lifelancer Full time

    About Us:Becton, Dickinson and Company is a leading global medical technology company that serves healthcare professionals and their patients in more than 190 countries.We are committed to advancing the world of health by developing innovative solutions that improve patient outcomes and enhance the quality of life for people around the world.Job Summary:The...


  • San Francisco, California, United States Chime Full time

    About the RoleChime is seeking a highly organized and detail-oriented Regulatory Response Associate to join our Compliance team. This role provides an excellent opportunity for a talented compliance professional to deploy their program management skills in a fast-paced environment, enhance their knowledge of regulatory affairs, and contribute to ensuring...


  • San Diego, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott is a global healthcare leader committed to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, encompassing diagnostics, medical devices, nutritionals, and branded generic medicines.We serve over 160 countries worldwide, with a diverse team of...


  • San Diego, California, United States Arrowhead Pharmaceuticals Full time

    We are seeking a highly skilled Clinical Safety Associate to join our team at Arrowhead Pharmaceuticals. This is an exciting opportunity for a detail-oriented professional to contribute to the execution of safety and pharmacovigilance operations.Job Description:The Clinical Safety Associate will be responsible for ensuring the flawless execution of safety...

  • Compliance Engineer

    5 days ago


    San Jose, California, United States WOTM - Partners Professional Full time

    Job OverviewWe are seeking a skilled Compliance Engineer to join our team in San Jose, CA. The ideal candidate will have a strong technical background and be familiar with various technologies and methodologies.Key Responsibilities:Conducting compliance testing for various projectsCollaborating with cross-functional teams to define, design, and ship new...


  • South San Francisco, California, United States Spirair, Inc. Full time

    Join Our Team as a Regulatory Compliance Engineer!Spirair, Inc. is a leader in the medical device industry, committed to delivering high-quality products that meet or exceed regulatory standards. As a Quality Engineer at Spirair, you will be responsible for supporting our Quality Management System, ensuring compliance with FDA regulations and industry...


  • San Francisco, California, United States Atlantic Group Full time

    What You'll DoYou will assist with preparation and completion of annual compliance risk assessments and reviews. Additionally, you will help administer the firm's Code of Ethics, including trade approvals, trade reviews, affirmation approvals, quarterly transaction reporting, and annual attestations. Furthermore, you will assist with legal and compliance...


  • San Francisco, California, United States Crowe Full time

    Your career at Crowe can be a journey of growth, innovation, and impact. With flexible work arrangements, you have the freedom to balance your work life with personal moments, delivering results that matter. We value diversity, care for your well-being, and foster an environment where everyone has equal opportunities for career advancement and...


  • San Mateo, California, United States Tbwa ChiatDay Inc Full time

    Corporate Counsel, Product Regulatory & ComplianceWe strive to create an inclusive environment that empowers employees and embraces diversity. As Corporate Counsel, you'll work closely with teams across our global business to establish processes and compliance programs to support the Product Regulatory function.About UsSony Interactive Entertainment is a...


  • San Diego, California, United States Lifelancer Full time

    At Lifelancer, we connect talent with opportunities in life sciences, pharma, and IT. Our platform helps professionals grow their careers in a variety of domains.We are seeking an experienced Regulatory Affairs professional to join our team as a Senior Manager. This role will play a crucial part in supporting regulatory needs across the business, from...


  • San Diego, California, United States Cypress HCM Full time

    About Cypress HCMCypress HCM is a leading company in the medical device industry, dedicated to providing innovative solutions for regulatory affairs and product development.


  • San Mateo, California, United States PlayStation Global Full time

    Job DescriptionAs a Product Regulatory and Compliance Lawyer at PlayStation Global, you will play a crucial role in shaping the company's regulatory strategy and ensuring compliance with relevant laws and regulations.About UsWe are a leading global entertainment brand that produces innovative products and services. Our team is passionate about creating an...


  • San Francisco, California, United States Sia Partners Full time

    Job OverviewSia Partners, a next-generation management consulting firm, is seeking a skilled Regulatory Compliance Management Specialist to join our team. This role offers the opportunity to work closely with clients' Compliance and Legal leadership teams, leading cross-functional initiatives around Compliance, Data Privacy, Legal Operations, and Process.We...


  • San Diego, California, United States Cypress HCM Full time

    Cypress HCM seeks a skilled Regulatory Affairs Specialist to coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. This role involves coordinating clinical study trials, including offsite locations as needed.Key ResponsibilitiesSubmission...