81 regulatory specialist jobs at 58 companies in Fallbrook, CA
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Senior Regulatory Affairs Specialist
San Diego, California, United States
$91k-$152k/yrHybridFull Time
DexcomNasdaq: DXCM: Manufacturer of continuous glucose monitoring systems for diabetes management.
5+ YOE5+ years regulatory affairs experience for medical devices, proficiency with US and EU device regulations, experience supporting 510(k)/license/technical documentation submissions, strong technical writing and communication.
2+ YOEBachelor's degree required (Master's preferred),2+ years in higher education compliance/accreditation,knowledge of accreditation standards,project management and documentation skills,Microsoft Office proficiency.
DexcomNASDAQ: DXCM: Develops continuous glucose monitoring systems for diabetes management.
2+ YOEBachelor’s degree typically required with 2+ years related experience; knowledge of US/international regulatory requirements, medical device software (IEC 62304), labeling, submissions (510(k), Health Canada, EU MDR) and strong technical writing skills.
Marlborough or Irvine or Arden Hills or Maple Grove
$89k-$170k/yrHybridFull Time
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
4+ YOEBachelor’s degree in a scientific or technical discipline, 4+ years of medical-industry regulatory affairs experience, and experience with 510(k), EU MDR, or international regulatory registrations.
Glidewell: Designs and manufactures custom dental restorations and laboratory products.
5+ YOE5+ years regulatory affairs experience, experience with FDA 510(k)/PMA and international registrations, SOP and audit experience, strong analytical and communication skills.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
Irvine or Marlborough or Arden Hills or Maple Grove
$89k-$170k/yrHybridFull Time
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
4+ YOEBachelor's degree in a scientific, technical, or related discipline and 4+ years of medical industry regulatory affairs experience, including 510(k), EU MDR, or international registrations.
Ventura Foods: Manufactures custom food solutions for foodservice and retail businesses.
3+ YOE3+ years' regulatory compliance experience in food/beverage/pharmaceutical, knowledge of global food laws, label and ingredient compliance, strong communication and project leadership skills.
Microsoft Office, PIM, Decernis gComply, Decernis gComply Plus, Trustwell/Genesis
StrykerNYSE: SYK: Manufactures medical devices and equipment for healthcare providers.
4+ YOEBachelor's in engineering, life sciences, regulatory science or related; minimum 4 years regulatory affairs experience in medical device/biotech/pharma; experience with international submissions and interpreting global regulations.
3+ YOE3+ years medical device regulatory experience (Class II/III), expert knowledge of FDA and international regulations, ISO 13485 and FDA/GMP experience, 510(k) submissions, MS Office proficiency, bachelor\u0002s degree preferred.
Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft Outlook
Neurocrine BiosciencesNASDAQ: NBIX: Develops pharmaceuticals for neurological, endocrine, and psychiatric disorders.
4+ YOEBS/BA with 4+ years, or MS with 2+ years, or JD/PhD/PharmD with no experience; strong regulatory knowledge, FDA/ICH familiarity, project management, teamwork, and communication.
JenaValve Technology: Developing transcatheter heart valve systems for aortic disease treatment.
3+ YOE3–5 years medical device regulatory affairs experience, bachelor’s in a scientific discipline, knowledge of global medical device regulations and quality systems, strong writing and communication skills, and ability to manage submissions and adverse event reporting.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
2+ YOEBachelor's degree (or equivalent), 2+ years in a regulated industry, strong regulatory knowledge for medical devices, submission experience, teamwork and communication skills.
Electronic Document Management Systems (EDMS), Product Lifecycle Management (PLM)
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
2+ YOEBachelor's degree or equivalent, 2+ years in a regulated industry, knowledge of medical device regulations, strong written/verbal communication, and experience preparing regulatory submissions.
Edwards LifesciencesNYSE: EW: Designs and manufactures medical devices for structural heart disease.
5+ YOEBachelor's degree (or equivalent), minimum 5 years related experience, experience preparing domestic and international medical device submissions, knowledge of global regulations for Class II/III devices.
General Atomics: Designs and manufactures unmanned aircraft and nuclear technology systems.
10+ YOEBachelor's degree or equivalent experience, ~10 years finance/accounting experience at government contractor preferred, knowledge of FAR and cost accounting, strong analysis, communication, and ERP (SAP) skills.
Senior Regulatory and Scientific Affairs Specialist (Remote)
Bridgewater or Dallas or Boston or Chicago or San Diego or New Jersey
$85k-$110k/yrRemoteFull Time
NestléSIX Swiss Exchange: NESN: Produces and sells a wide range of food and beverages.
4+ YOEBachelor's degree in food science, nutrition, chemistry, or related science; 4+ years in food or supplement regulatory work; project management, compliance, and problem-solving skills; national travel availability.
Regulatory & Compliance HC Specialist 4 - Risk Management FT Days
Orange, California, United States
$123k-$238k/yrOnsiteFull Time
University of California, Irvine: Public research university offering higher education and academic degrees.
5+ YOEFive years in hospital quality or regulatory compliance; knowledge of CMS, California regulations, and Joint Commission standards; bachelor's degree in a health-related field, RN, or equivalent experience; strong analytical and communication skills.
CMS, The Joint Commission, California Department of Public Health (CDPH)
Applied Medical: Manufacturer of advanced medical devices and surgical products.
1+ YOE1+ year regulatory affairs or quality assurance experience in medical devices; proficiency interpreting regulations/standards; strong technical writing, communication, and analytical skills; motivated self-starter.
Avanath: Acquires and manages affordable and workforce apartment communities.
2+ YOE2+ years affordable multi-housing/property management experience, Certified Occupancy Specialist (or similar), familiarity with housing agencies and LIHTC/HUD compliance, strong regulatory interpretation skills, and Yardi Voyager and Microsoft Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Access, Yardi Voyager