Regulatory Affairs Specialist

3 days ago


San Diego, California, United States Cypress HCM Full time
Job Overview:
Cypress HCM is seeking a skilled Regulatory Affairs Specialist to coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies.

About the Role:
This Regulatory Affairs Specialist will be responsible for coordinating clinical study trials, including offsite locations as needed. The ideal candidate will have excellent written and oral communication skills, with the ability to write clear, understandable technical documentation.

Responsibilities:
* Coordinates submission and review of documents for inclusion in Design History files.
* Drafts, edits, and compiles technical documentation and design dossier in support of CE mark/UKCA mark regulatory filings.
* Responsible for the preparation of post-market product surveillance reports and EU/UK vigilance reports as needed.
* Prepares regulatory submissions for FDA A2F and assists on the Registration/Application of Class II & III Medical Devices Licenses in Health Canada.
* Researches FDA, CMDR, MDR, IVDR, and UK MDR 2002 guidance documents for regulatory requirements and reviews labeling, package inserts, ad materials, and company website to meet FDA and CE regulatory requirements.
* Maintains, tracks, and/or updates regulatory documentation and Essential Requirements Checklists- ensuring that applicable standards are utilized and updated as revisions are introduced.
* Provides Technical Documentation to Competent Authorities and Notified Bodies and assists OEM customers in obtaining the CE mark on their products.

Requirements:
* Bachelor's degree in a related discipline or equivalency;
* Minimum 6-7 years IVD industry experience with a minimum 3 years' experience in preparation and submission of 510k or CE technical files for IVD devices;
* Strong working knowledge of medical devices regulations and terminologies; Excellent written and oral communication, and technical writing and editing skills; Ability to write clear, understandable technical documentation;
* Proficient with Microsoft Office and ability to manage and prioritize multiple projects;
* Ability to follow written and verbal direction with a high level of accuracy and work in a team setting;
* Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.

What We Offer:
* Salary range: $90,000 - $120,000 per year;

  • San Diego, California, United States Lifelancer Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT.As a Senior Specialist, Regulatory Affairs, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and...


  • San Diego, California, United States CorDx Full time

    CorDx is a leading biotech organization pushing the boundaries of innovation and supply in global health. With over 2,100 employees worldwide, serving millions of users across 100 countries, we deliver rapid testing and point-of-care medical device solutions for infectious diseases like COVID-19, pregnancy, and more.We are at the forefront of technology,...


  • San Diego, California, United States Lifelancer Full time

    At Lifelancer, we connect talent with opportunities in life sciences, pharma, and IT. Our platform helps professionals grow their careers in a variety of domains.We are seeking an experienced Regulatory Affairs professional to join our team as a Senior Manager. This role will play a crucial part in supporting regulatory needs across the business, from...


  • San Diego, California, United States CorDx Full time

    **About the Role:**The Regulatory Affairs Manager will play a crucial role in ensuring compliance with regulatory requirements and guiding the development of new medical devices at CorDx. This position requires strong leadership skills, excellent communication abilities, and a deep understanding of FDA regulations and ISO standards.**Key...


  • San Diego, California, United States Lifelancer Full time

    About Us:Becton, Dickinson and Company is a leading global medical technology company that serves healthcare professionals and their patients in more than 190 countries.We are committed to advancing the world of health by developing innovative solutions that improve patient outcomes and enhance the quality of life for people around the world.Job Summary:The...


  • San Fernando, California, United States American Fruits & Flavors Full time

    Job SummaryAmerican Fruits & Flavors is seeking an experienced Supervisor of Regulatory Affairs to oversee the development and implementation of regulatory compliance strategies.Key ResponsibilitiesSupervise a team of Regulatory Affairs Specialists and provide guidance on regulatory compliance and procedures.Develop and implement regulatory compliance...


  • San Diego, California, United States BioPhase Solutions Full time

    Job OverviewBioPhase Solutions is seeking a skilled Regulatory Affairs Specialist to join our team in San Diego, CA. As a key member of our organization, this role will focus on managing and maintaining documentation processes to ensure compliance with company policies and industry standards.ResponsibilitiesDocumentation Management: Coordinate the creation,...


  • San Diego, California, United States Cypress HCM Full time

    About Cypress HCMCypress HCM is a leading company in the medical device industry, dedicated to providing innovative solutions for regulatory affairs and product development.


  • San Fernando, California, United States AppleOne Employment Services Full time

    We are seeking a skilled Regulatory Affairs Specialist to join our team at AppleOne Employment Services. In this role, you will be responsible for supervising and supporting the Regulatory Department, ensuring compliance with existing and emerging regulations, standards, guidance documents, and international laws. This includes TTB, IFRA, Kosher, halal,...


  • San Diego, California, United States Dennis Partners Full time

    Company OverviewThe clinical-stage biotech company, Dennis Partners, is a dynamic organization focused on developing innovative small molecule therapeutics for the treatment of devastating cancers and immune disorders. With multiple programs in clinical trials and a rapidly growing clinical portfolio, this is an exciting time to join our team as a Vice...


  • San Diego, California, United States California Coast Credit Full time

    California Coast Credit Union seeks a seasoned Compliance and Regulatory expert to serve as our AVP, Regulatory Affairs. In this key role, you will be responsible for designing, developing, deploying, and managing our Regulatory Compliance Program to ensure our organization remains compliant with all applicable requirements and laws.Primary...


  • San Diego, California, United States Lifelancer Full time

    Company OverviewBecton, Dickinson and Company is a leading global medical technology company that develops innovative solutions to help healthcare professionals improve patient outcomes. Our purpose is to advance the world of health by delivering meaningful innovations that bring value to our customers, patients, and communities.Salary RangeWe offer a highly...


  • San Diego, California, United States Lifelancer Full time

    OverviewCrinetics Pharmaceuticals is a pioneering biotech company dedicated to developing innovative therapies for endocrine diseases and tumors. Our mission is to transform lives through rigorous innovation, patient-centric culture, and a team-oriented approach.We are seeking a highly skilled Manager, Regulatory Affairs to join our team in San Diego, CA....


  • San Diego, California, United States Lifelancer Full time

    At Lifelancer, we're committed to connecting top talent with opportunities in pharma, biotech, health sciences, and IT domains. We're currently seeking a highly skilled Regulatory Affairs Expert to join our team.About the RoleThis is an exceptional opportunity for a seasoned Regulatory Affairs professional to take on a challenging role that requires...


  • San Jose, California, United States Top Group Full time

    About UsWe are a leading talent acquisition and people operation group that connects people to careers and professional growth. We are committed to providing exceptional services to our clients and candidates.Job DescriptionWe are seeking a highly skilled Chemical Regulatory Affairs Specialist to join our team. As a key member of our organization, you will...


  • San Diego, California, United States Cypress HCM Full time

    Job Title: Regulatory Affairs SpecialistJob Summary: Cypress HCM is seeking a dedicated Regulatory Affairs Specialist to coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies.Key Responsibilities:Submission Coordination: Coordinate the...


  • San Mateo, California, United States Fladger Assoc. Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs CMC Associate to join our team at Fladger Assoc. Inc. in Foster City, CA. This is an exciting opportunity for a professional with a strong background in regulatory affairs and experience in supporting biologic and small molecule drugs.About the RoleThe successful candidate will provide regulatory...


  • San Diego, California, United States Cypress HCM Full time

    Cypress HCM seeks a skilled Regulatory Affairs Specialist to coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. This role involves coordinating clinical study trials, including offsite locations as needed.Key ResponsibilitiesSubmission...


  • San Diego, California, United States BioPhase Solutions Full time

    Regulatory Affairs SpecialistAt BioPhase Solutions, we are seeking a highly skilled Regulatory Affairs Specialist to join our team in San Diego. This role will play a critical part in ensuring compliance with industry standards and company policies. The ideal candidate will have experience managing documentation processes and supporting quality systems.Key...


  • San Diego, California, United States General Atomics Full time

    Job OverviewWe are seeking an experienced Corporate Attorney to join our team at General Atomics. As a key member of our legal department, you will provide critical support to the company's business operations and ensure compliance with relevant laws and regulations.About the RoleThis is a highly visible position that requires a strong understanding of...