Regulatory Affairs Specialist: Average Salary in California in 2025

A company is looking for a Senior Regulatory Affairs Specialist - IVD. ...

Specialist of Regulatory Affairs you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Minimum of 5 years of strong Regulatory Affairs...

Senior Specialist, Regulatory Affairs. Responsible for global regulatory affairs communication, regulatory negotiation and correspondence tracking, serious adverse event reporting, post-market surveillance, competitive intelligence, and maintenance of standards program. Maintain regulatory intellige...

As a Staff Regulatory Affairs Specialist in Advertising/Labeling, you will play a crucial role in supporting Medication Management Solutions (MMS) Dispensing products, including Medical Devices, Non-Medical Devices, associated Software, and Accessories on a global scale. Support regulatory impact as...

This RA Specialist will play a key role in managing China RA regulatory intelligence, working closely with the in-country RA team to facilitate China regulation and standard assessment. This position will also collaborate with the local RA team, the Product Localization Engineering (PLE), and other ...

Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed. Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements...

In this role, you will work with the Regulatory Affairs team which ensures Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will work under direct supervision and be responsible for the coordination...

Regulatory Affairs Operations Specialist I. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifi...

Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements with a focus on the United States and the EU. Regulatory Affairs Specialist is an individual contributor ...

The Staff Regulatory Affairs Specialist is part of the team responsible for Core Business New Product Development with a focus on compliance to regulations from the US Food Drug & Administration (FDA) and the EU In Vitro Diagnostic Regulation (IVDR). This individual will be responsible for leading t...

Preferred: Regulatory Affairs, Domestic Regulatory Affairs, or Regulatory Affairs Essentials. Compliance & Regulatory Affairs Specialist. The Compliance & Regulatory Affairs Analyst I position is responsible for maintaining all licenses and permits necessary for the daily operations of all locations...

This position is responsible for handling time sensitive Regulatory documents in accordance with appropriate regulatory agencies and internal company procedures. Assists with regulatory submissions, annual reports, and regulatory responses. Assist Regulatory Management with product deviation reporti...

Opportunity to join a global diagnostics company's Regulatory Affairs team, to be the SME and lead all regulatory activities for one of the organization's most exciting product lines. Regulatory Affairs experience within life sciences, with 4 years in the IVD space submitting 510(k)s and/or IVDR tec...

Responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulat...

The Senior Regulatory Affairs Specialist will collaborate across teams to manage complaint reporting, support audits, and ensure compliance with EU MDR and other applicable regulatory standards. The Senior Regulatory Affairs Specialist will play a critical role in ensuring that the company’s medical...

As a Staff Regulatory Affairs Specialist in Advertising/Labeling, you will play a crucial role in supporting Medication Management Solutions (MMS) Dispensing products, including Medical Devices, Non-Medical Devices, associated Software, and Accessories on a global scale. Support regulatory impact as...

The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...

Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a  Sr Regulatory Affairs S...

Sr Regulatory Affairs Specialist This position is based in our Campbell, California offices. In consultation with responsible Regulatory Affairs Management, interact and negotiate directly with regulatory authorities during the product development and review process to facilitate submission approval...

As a Staff Regulatory Affairs Specialist in Advertising/Labeling, you will play a crucial role in supporting Medication Management Solutions (MMS) Dispensing products, including Medical Devices, Non-Medical Devices, associated Software, and Accessories on a global scale. Support regulatory impact as...

This RA Specialist will play a key role in managing China RA regulatory intelligence, working closely with the in-country RA team to facilitate China regulation and standard assessment. This position will also collaborate with the local RA team, the Product Localization Engineering (PLE), and other ...

Bachelor’s degree in Engineering, Physical or Biological Sciences, Regulatory, other technical disciplines, or equivalent. ...

Senior Regulatory Affairs Specialist (Multiple Positions), Becton Dickinson and Company, Milpitas, CA. Apply deep understanding of global regulatory landscape to analyze and compile country-specific regulatory requirements. Device/diagnostic, biologic, or pharmaceutical industry in Regulatory Affair...

With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs. Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files. Candidate expertise includes det...

As a Senior Specialist, International Regulatory Affairs, you complete and maintain regulatory approvals and clearances of assigned products. Representing the OUS regulatory function on manufacturing and product development teams to providing input on regulatory requirements, including presenting al...