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Recor Medical
Palo Alto, CA, United States
At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join
Job Source: Recor MedicalNet2source
Palo Alto, CA, United States
Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension) Pay Rate: $68.89/hr. Location: Palo Alto CA USA 94304 Hybrid Need Local Candidates to Palo Alto CA Job role required to support tasks for software and VBT projects. Position Description: *Perform the coordination and preparation of regulatory submissions for brach
Job Source: Net2sourceGForce Life Sciences
Santa Clara, CA, United States
Regulatory Affairs Project Lead– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry. Key Resp
Job Source: GForce Life SciencesRandstad Life Sciences US
San Jose, CA, United States
Regulatory Affairs Specialist San Jose, CA - Hybrid (3 days on site / 2 days remote) Pay: $45 - $50/hr based on experience About this opportunity The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing fo
Job Source: Randstad Life Sciences USHire Talent
Santa Clara, CA, United States
Position: Regulatory Affair Specialist Location: Santa Clara, CA Duration: 1+ year of contract Responsibilities: Registrations - will train to do this Upto 200 pages of documentation formatting Complete technical documents for different Countries and submit to government agencies as well as the US. Knowledge of US and/or Canadian regulations or wit
Job Source: Hire TalentIntellectt Inc
Santa Clara, CA, United States
Hello, I Hope you are doing great. This is Bhanu from Intellectt INC; we’ve got an important role Regulatory Affairs Compliance Specialist - Santa Clara, CA with one of our prestigious clients. Interested candidates can please send your updated resume at [email protected] Role: Regulatory Affairs Compliance Specialist Location: Santa C
Job Source: Intellectt IncAlign Technology, Inc.
San Jose, CA, United States
Join a team that is changing millions of lives. Transforming smiles , changing lives. At Align Technology , we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign syst
Job Source: Align Technology, Inc.Nevro Corp.
Redwood City, CA, United States
About Nevro: Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from de
Job Source: Nevro Corp.Mountain View, CA, United States
Reports to: Senior Director of Regulatory and Quality
Salary Range: 140-160K
Location: San Jose, CA (hybrid position)
This is an established privately held medical device company with a focus in delivering innovative navigation diagnostic and therapeutic technologies. Their reach is global and they are the industry leader in their specialty, with a second location in Asia. The investment into R&D is significant with several products in the pipeline at various stages and their financial standings are strong.
The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed.
Responsibilities
Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction.
Provide guidance and approval regarding regulatory strategies and approaches.
Develop, Maintain and update regulatory documents such as technical files for CE marking, device master records, GSPR checklist, risk analysis, and design history files.
Participate and Support new product development teams to provide regulatory support to the project.
Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging and notifying regulatory agencies and NB of substantial changes.
Support post market activities and reportability to regulatory agencies.
Required to support communication with FDA and the Notified Body, preparing responses to questions or deficiency letters from regulatory agencies, and serve as the RA Representative during FDA and NB site audits.
Qualifications 5-10 years experience in regulatory affairs within the medical device industry
Strong experience in EUMDR Regulations (Medical Device directives (93/42/EC)
Authoring experience in FDA product submissions (IDE, PMA, 510k)
Experience in writing/maintaining CE Technical Files preferred
Experience with ISO 13485:2016 and ISO 14971
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Email Alert for Principal Regulatory Affairs Specialist jobs in Mountain View, CA, United States
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