Current jobs related to Regulatory Compliance Specialist - San Diego, California - Cypress HCM
-
Regulatory Compliance Specialist
7 days ago
San Francisco, California, United States Katalyst HealthCares and Life Sciences Full timeJob Summary:As a Regulatory Compliance Specialist at Katalyst HealthCares and Life Sciences, you will be responsible for ensuring the validation and regulatory compliance of computerized systems in GxP and GAMP regulated environments. This includes planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation...
-
Regulatory Compliance Specialist
1 week ago
San Francisco, California, United States DANIEL DEFENSE LLC Full timeRegulatory Compliance SpecialistDaniel Defense LLC is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our compliance department, you will be responsible for ensuring that our company is in compliance with all relevant laws and regulations.Key Responsibilities:Manage the day-to-day operations of serialized...
-
Regulatory Compliance Specialist
1 week ago
San Francisco, California, United States BCforward Full timeJob SummaryWe are seeking a highly motivated and experienced Regulatory Compliance Specialist to join our team at BCforward. As a key member of our Clinical Development and Supply division, you will be responsible for ensuring compliance with global regulations and industry standards.Key ResponsibilitiesManage the supplier quality program and ensure Supplier...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Coordinate the preparation and...
-
Regulatory Affairs Specialist
1 week ago
San Diego, California, United States Ajinomoto Bio-Pharma Full timeRegulatory Affairs SpecialistAjinomoto Bio-Pharma is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing support for all internal and external regulatory-related activities.Key Responsibilities:Collaborate with internal team members to maintain compliance with...
-
Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States Tandem Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Prepare and maintain domestic and international regulatory...
-
San Francisco, California, United States Katalyst Healthcares and Life Sciences Full timeWe're seeking a highly skilled Regulatory Compliance Specialist for Computer Systems to join Katalyst Healthcares and Life Sciences. This exciting opportunity will allow you to utilize your expertise in 21CFR Part 11 systems validation and regulatory compliance to ensure the highest standards of quality and safety in our computerized systems.About UsKatalyst...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States Bayside Solutions Full timeJob Title: Regulatory Specialist, R&DBayside Solutions, Inc. is seeking a highly skilled Regulatory Specialist to join our R&D team. As a Regulatory Specialist, you will play a critical role in implementing worldwide regulatory programs for developing and marketed products and interacting with regulatory authorities to expedite approvals.Key...
-
Compliance Specialist
1 week ago
San Francisco, California, United States Compliance Solutions Inc Full timeAbout Compliance Solutions IncCompliance Solutions Inc is a leading provider of AI safety and research solutions. We are committed to building reliable, interpretable, and steerable AI systems that are safe and beneficial for our customers and society as a whole.Job DescriptionWe are seeking a highly skilled Compliance Specialist to join our team. The...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...
-
Regulatory Affairs Specialist
3 days ago
San Diego, California, United States CorDx Full timeAt CorDx, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for assisting in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.The ideal candidate will have a strong understanding of regulatory...
-
Regulatory Affairs Specialist
3 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...
-
Regulatory Compliance Specialist
3 weeks ago
San Luis Obispo, California, United States Adventist Health Full timeJob SummaryAdventist Health is seeking a highly skilled Regulatory Specialist to support the work of our accreditation program. This role will be responsible for processing accreditation report reviews, coordinating site visits, and maintaining accreditation program files. The ideal candidate will have a strong understanding of accreditation regulations and...
-
Regulatory Affairs Specialist II
1 week ago
San Diego, California, United States Abbott Laboratories Full timeJoin Abbott Laboratories as a Regulatory Affairs Specialist IIAt Abbott Laboratories, we are committed to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.We are...
-
Corporate Attorney
2 weeks ago
San Diego, California, United States Consilio Full timeJob Title: Corporate AttorneyLegility + Consilio is seeking a highly skilled Corporate Attorney with expertise in Life Sciences and Regulatory Compliance to join our team. As a key member of our legal operations team, you will provide strategic counsel to commercial, market access, and medical affairs functions for new and existing projects in the...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States Bayside Solutions Full timeJob Title: Regulatory Specialist, R&DJob Summary:We are seeking a highly skilled Regulatory Specialist to join our R&D team. As a key member of our team, you will be responsible for implementing worldwide regulatory programs for developing and marketed products, interacting with regulatory authorities to expedite approvals, and providing regulatory expertise...
-
Regulatory Affairs Specialist
2 days ago
San Diego, California, United States Dexcom Full timeAbout the Role:Dexcom is seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as an Intern. As a Regulatory Affairs Specialist, you will play a critical role in preparing, submitting, and gaining regulatory approvals for our life-changing products, therapies, and customers around the world.Key...
-
Chief Compliance Officer
2 months ago
San Diego, California, United States LendSure Mortgage Corp. Full timeJob SummaryLendSure Mortgage Corp. is seeking a seasoned Compliance Leader to oversee the company's mortgage regulatory compliance operations. As a key member of our team, you will be responsible for ensuring that our business practices align with federal and state regulations.Key ResponsibilitiesRegulatory Guidance: Provide expert guidance on all federal...
-
Regulatory Affairs Specialist
3 days ago
San Diego, California, United States Neurocrine Biosciences Full timeJob Title: Regulatory Affairs Specialist - CMCNeurocrine Biosciences is seeking a highly skilled Regulatory Affairs Specialist - CMC to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and execution of regulatory strategies for assigned commercial and development projects.Key...
-
Regulatory Affairs Specialist II
3 days ago
San Diego, California, United States Abbott Laboratories Full timeAt Abbott Laboratories, we're seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our Regulatory Affairs department, you'll play a critical role in ensuring compliance with US, EU, and international regulations and standards for our diagnostic products.Key Responsibilities:Provide regulatory support for diagnostic...
Regulatory Compliance Specialist
2 months ago
Regulatory Affairs Specialist
The Regulatory Affairs Specialist IV at Cypress HCM will oversee the organization and submission of regulatory documents related to in vitro diagnostics and medical device licenses to appropriate regulatory bodies. This role will also involve managing clinical trial studies, including those conducted at external sites when required.
Key Responsibilities
- Facilitate the submission of documents for Design History files.
- Draft, revise, and compile technical documentation necessary for regulatory submissions.
- Prepare reports for post-market product surveillance and vigilance.
- Submit regulatory applications and support the acquisition of CE marks for products.
- Investigate regulatory requirements and evaluate labeling and website content.
- Maintain and refresh regulatory documentation and requirements checklists.
- Provide technical documentation to regulatory authorities and OEM clients.
Qualifications
- Bachelor's degree in a relevant field;
- A minimum of 6-7 years of experience in the IVD sector, with at least 3 years focused on 510k or CE technical file preparation.
Skills and Competencies
In-depth knowledge of medical device regulations and terminology;
Excellent written and verbal communication abilities;
Strong analytical skills with the capability to summarize data effectively;
Proficient in Microsoft Office Suite.
