Regulatory Coordinator
4 weeks ago
Requirements
Responsibilities
Assist in the preparation, submission, and maintenance of regulatory filings and registrations, including 510(k) and PMA submissions.
Interpret and communicate industry and regulatory guidance to internal teams.
Coordinate with cross-functional teams to ensure compliance with regulatory requirements.
Manage documentation related to regulatory submissions and approvals.
Prepare post-market surveillance reports, adverse event reports, and other regulatory reports.
Track and maintain regulatory compliance metrics.
Participate in regulatory agency inspections.
Requirements
Bachelor's degree in biology, chemistry, or a related field.
2+ years of experience in regulatory affairs in the biotechnology industry.
Knowledge of FDA regulations, including 21 CFR, 510(k), and PMA requirements.
Strong organizational and project management skills.
Excellent written and verbal communication skills.
Ability to work collaboratively with cross-functional teams.
Detail-oriented with strong analytical skills.
Benefits
Health Care Plan (Medical)
Retirement Plan
Paid Time Off
Training & Development
Company Sponsored Meals
Individual and Team Bonding Spending
Apply for this job
-
Regulatory Coordinator
3 weeks ago
San Diego, United States CorDx Full timeJob DescriptionJob DescriptionCorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal...
-
Regulatory Coordinator
4 weeks ago
San Diego, United States CorDx Full timeCorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal candidate will be detail-oriented...
-
Regulatory Coordinator
3 weeks ago
San Diego, United States CorDx Full timeJob DescriptionJob DescriptionCorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal...
-
Regulatory Coordinator
3 weeks ago
San Diego, United States CorDx Full timeJob DescriptionJob DescriptionCorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal...
-
Coordinator, Regulatory
7 days ago
San Diego, United States Rady Children's Hospital-San Diego Full timeJOB SUMMARY: In collaboration with the Director of Regulatory and Accreditation Programs, assists in all accreditation & regulatory activities, including survey preparation & readiness assessments for all facilities accredited by the Joint Commission. The position is very independent & deals with sensitive and confidential regulatory information daily. This...
-
Regulatory Affairs Specialist
2 weeks ago
San Diego, United States Cypress Human Capital Management, LLC Full timeRegulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...
-
Regulatory Affairs Specialist
2 weeks ago
San Diego, United States Cypress HCM Full timeRegulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...
-
Regulatory Affairs Specialist
1 month ago
San Diego, United States Cypress HCM Full timeRegulatory Affairs SpecialistThe Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...
-
Regulatory Affairs Specialist
1 month ago
San Diego, United States Cypress HCM Full timeRegulatory Affairs SpecialistThe Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...
-
Director of Regulatory Strategy
1 month ago
San Diego, United States Cypress HCM Full timeThe role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...
-
Director of Regulatory Strategy
1 month ago
San Diego, United States Cypress HCM Full timeThe role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...
-
Staff Regulatory Specialist
3 days ago
San Diego, United States Werfen Full time**Job Overview**: - Post Date - May 23, 2024 - Number - ICIMS-2023-6590 - Job Function - QA&RA - Location - San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States - Country - United States - Shift - 1st **About the Position**: **Overview**: **Werfen** *** Werfen, founded in 1966, is a worldwide developer, manufacturer and...
-
Head of Training, Quality
2 weeks ago
San Diego, CA, United States SCA Health Full timeToday, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality outcomes...
-
Regulatory Coordinator
4 weeks ago
San Antonio, United States University Health System- San Antonio Full timePOSITION SUMMARY/RESPONSIBILITIES Coordinates the daily operation of the UH Facilities Management department central Work order program . Complies with UH and departmental policies. Maintains good customer and personnel working relations. EDUCATION/EXPERIENCE A high school diploma or equivalent is required. Graduation from a two year technical college in a...
-
Sr. Counsel Litigation
1 month ago
San Antonio, United States HEP Services LLC Full timeJob DescriptionJob DescriptionThis position will provide primary legal support for HEP’s litigation activities and will be responsible for managing outside litigation counsel, coordinating HEP’s internal discovery efforts and working closely with HEP’s insurance team and applicable insurance carriers on matters involving insurance coverage....
-
Environmental Health
2 days ago
San Diego, United States Kaygen Full time3 Must haves on the resume: - o Experience working within a biotech or laboratory setting in a safety roleo Experience or broad knowledge of EHS programso Ability to take direction routinely - Education req. Aid in the management and administration of all site safety and environmental programs, including Chemical Hygiene, Biological Safety, and Fire...
-
Clinical Research Coordinator
3 weeks ago
San Diego, United States Rady Children's Hospital San Diego Full timeJOB SUMMARY: Under supervision, the Clinical Research Coordinator will be assigned to assist with multiple clinical research studies involving human subjects within the research unit/department. Assist with initiation, implementation and management of research projects in accordance with GCP, FDA, HIPAA & all required regulatory guidelines, with an emphasis...
-
Project Coordinator
7 days ago
San Diego, United States Pride Resource Partners Full time**NOTE: This is a hybrid scenario, reports in-office 2 days per week. We are only considering candidates local to San Diego, CA.**Our Company:Pride Resource Partners, LLC (PRPLLC) is a California based high-performance Project Management consulting firm. Pride is a local small business and CPUC Certified Diverse Business Enterprise. PRPLLC provides expert...
-
Project Coordinator
3 days ago
San Diego, United States Pride Resource Partners Full time**NOTE: This is a hybrid scenario, reports in-office 2 days per week. We are only considering candidates local to San Diego, CA.**Our Company:Pride Resource Partners, LLC (PRPLLC) is a California based high-performance Project Management consulting firm. Pride is a local small business and CPUC Certified Diverse Business Enterprise. PRPLLC provides expert...
-
Project Coordinator
7 days ago
San Diego, United States Pride Resource Partners Full time**NOTE: This is a hybrid scenario, reports in-office 2 days per week. We are only considering candidates local to San Diego, CA.**Our Company:Pride Resource Partners, LLC (PRPLLC) is a California based high-performance Project Management consulting firm. Pride is a local small business and CPUC Certified Diverse Business Enterprise. PRPLLC provides expert...