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Alameda Health System
San Carlos, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemAscendis Pharma
Palo Alto, CA, United States
Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We are applying our TransCon tech
Job Source: Ascendis PharmaNevro
Redwood City
Regulatory Affairs Manager Company: Nevro Location: Redwood City, CA Position Type: Full Time Experience: See below Education: See below Regulatory Affairs Manager at Nevro in Redwood City, CA Req. Master�s deg in RA, Biomedical Eng�g or Med. Devi...
Job Source: NevroNevro 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.Ascendis Pharma
Stanford, CA, United States
Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We are applying our TransCon tech
Job Source: Ascendis PharmaAscendis Pharma A/S
Palo Alto, CA, United States
Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We are applying our TransCon techno
Job Source: Ascendis Pharma A/SAlameda Health System
Castro Valley, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemAscendis Pharma
Palo Alto, CA, United States
Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues. We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, were advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. We are applying our TransCon technol
Job Source: Ascendis PharmaRedwood 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 debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally.
Nevros comprehensive HFX spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. Senza, Senza II, Senza Omnia, and Senza HFX iQ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. HFX iQ, Nevros latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief. Nevros unique support services provide every patient with an HFX Coach throughout their pain relief journey and every physician with HFX Cloud insights for enhanced patient and practice management.
Job Summary & Responsibilities:
Regulatory Affairs Manager, Redwood City, CA - Develop global regulatory strategies and submission activities for various new development and product modification of Nevros Senza spinal cord stimulation (SCS) system, an Implantable Class 3 medical device; ensure compliance with medical device regulations of U.S. federal code, FDA, E.U., and Australia; coordinate product development, commercialization, and post-launch product success and supports the marketplace competitiveness; develop clinical trial plans and reports which support clinical indication expansion products, in collaboration with cross-functional teams; prepare IDE, 510(k), PMA, CE Mark submissions; collaborate with R&D and Quality to determine and execute pre-clinical test plans in support of new product development regulatory submissions; apply regulatory knowledge in managing multiple projects; establish and lead communications with FDA, Notified Bodies, and other regulatory agencies; provide leadership and regulatory guidance to ensure timely and accurate documentation for regulatory submissions; apply scientific background to develop trial plans and reports; maintain knowledge of competitive technologies to stay current; develop, document and implement regulatory strategies for new technologies and product modifications. Remote work from anywhere in the US is permitted. (No agencies or phone calls please.) #LI-DNI
Role Requirements:
Requires Masters degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and six years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs, or a Bachelors degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and eight years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs.
Must possess Six years of experience with implantable Class 3 medical devices in the following:
Developing clinical trial plans and reports which support clinical indication expansion products, in collaboration with cross-functional teams;
Collaborating with cross-functional teams
Determining and executing pre-clinical test plans in support of new product development regulatory submissions in collaboration with R&D and Quality;
Providing leadership and guidance to ensure timely and accurate documentation for regulatory submissions;
Preparing PMA submissions for the FDA and global regulatory submissions in the European Union and Australia
Remote work from anywhere in the US is permitted.
Skills and Knowledge:
Be viewed as a leader by your manager, peers, and subordinates.
Be a problem solver and not just a problem communicator.
Demonstrated experience in preparing 510(k) and PMA submissions for FDA.
Demonstrated experience with global submissions (EU, Australia, Japan, etc.)
Strong interpersonal and analytical skills.
Excellent written and oral communication skills.
Excellent organizational and multi-project management skills and attention to detail.
Regulatory Affairs Certification (RAC) is preferred.
Target Pay Range:
$126,938 to $155,000
EEO Statement:
Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.
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Email Alert for Regulatory Affairs Manager jobs in Redwood City, CA, United States
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