Regulatory Affairs Specialist: salario promedio en Newport Beach, CA in 2024

A company is looking for a Regulatory Affairs Specialist I to manage regulatory documentation and submissions. ...

A leading provider in the health care and digital health space is seeking a Senior Regulatory Affairs Specialist to join their regulatory team. Minimum of 5 years of experience in medical device Regulatory Affairs with a deep understanding of regulatory frameworks. As a key player in regulatory over...

Job Description: Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA. Provide consultation and advice to regulatory specialists regarding change control and product development. Contribute to continuous improvement initiatives within the regulatory affairs function. Experience with Japa...

Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans. Exercise judgme...

The Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and a...

Regulatory Affairs Specialist II. On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE Marked under the IVD Directiv...

We are currently seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. Senior Regulatory Affairs Specialist. Hands-on experience with major regulatory submissions and managing interactions with regulatory agencies. Develop and implement gl...

Regulatory Affairs Specialist II. ...

We have partnered with a large medical equipment company in the Irvine, CA area to provide them with a Senior Regulatory Affairs Specialist. Prioritized Must Have Skills for the Senior Regulatory Affairs Specialist:. Requirements of the Senior Regulatory Affairs Specialist:. Benefits of the Senior R...

The Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and a...

This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Aides in the execution of the regulatory plan for the assigned market(s) based on the ...

Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans. Exercise judgme...

The role of the Regulatory Affairs Specialist will be to support the global regulatory affairs of the business with a specialized focus on the United States. This position will be primarily responsible for obtaining and maintaining all necessary United States federal and state regulatory approvals f...

This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Aides in the execution of the regulatory plan for the assigned market(s) based on the ...

As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy. From design to production, our Regulatory...

Regulatory Affairs Specialist II. ...

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...

Seeking a Senior Regulatory Affairs Specialist with expertise in US and EU regulatory requirements, EU MDR regulation, and medical device regulatory submissions to sustain the current product portfolio. Partner with the international regulatory affairs group to support regulatory submissions. In-dep...

From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...

EXPERIENCE AND EDUCATION • BS degree in Engineering, Physical or Biological science a minimum of 3 years of experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries, OR • Advanced degree 2 years of experience in Regulatory Affairs or o...

Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currenlty CE Marked under the IVD Directive.Activites include preparation  revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional n...

As a contributing member on product development and operation teams, at times act as sole representative from Regulatory to ensure regulatory compliance. Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved ...

Minimum five (5) years of experience in Regulatory Affairs. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections). Prepare and submit product registrations and submissi...

MsoNoSpacing">We have partnered with a large medical equipment company in the Irvine, CA area to provide them with a Senior Regulatory Affairs Specialist. Prioritized Must Have Skills for the Senior Regulatory Affairs Specialist:</b></p> <p style="margin-bottom:11px&quo...

Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currenlty CE Marked under the IVD Directive.Activites include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional no...