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Clinical Regulatory Affairs Specialist Jobs in San Diego, California

Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121 $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Senior Regulatory Affairs Specialist
By NuVasive, Inc. At , San Diego $96,000 - $160,000 a year
Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
Knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.
This position is remote eligible, but we prefer candidates commutable to our San Diego, CA office
Ability to determine, communicate and make recommendations for submission and approval requirements to others
Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs
Understanding of regulatory terminology, pre-market submission types, and requirements
Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121, Ca $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Regulatory Affairs Specialist(100% Remote) $95K
By CyberCoders At Carlsbad, CA, United States
3-5+ years of professional OUS EUMDR Regulatory Affairs experience
Experience with Medical Device Reg Affairs for implantable
Working knowledge of 21 CFR 820, ISO 13485, MDD, EU MDR, and MDSAP
Full Benefits: Medical, Dental, Vision for employee and all dependents!
Bleeding Edge Technology = smart device to control pain relief!
Maintain licenses/registrations in existing territories
Regulatory Affairs Specialist 1 Jobs
By Hologic At , San Diego, Ca $65,000 - $89,600 a year
Understanding of product life cycle process, design control and/or risk management.
Participate on product development core teams as regulatory representative and provide guidance on global regulatory requirements for new/existing products.
Interpret and clearly explain regulatory requirements and standards for IVDs and medical device products to cross-functional stakeholders.
Prepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned).
Bachelors with 1 years of experience or Masters with 0 year of industry experience or equivalent
Technical knowledge including (but not limited to) Biomedical/Life Sciences/Engineering/Clinical.
Regulatory Coordinator Iii/Clinical Researcher
By Cedars-Sinai At West Hollywood, CA, United States
Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical research/clinical trials.
May provide training and education to other personnel.
Participates in required training and education programs.
Five (5) years minimum of directly related experience; 2 years of regulatory experience and 3 years of clinical research experience.
Ability to identify areas of project interest and connect with appropriate support group: CCTO SPIN, IRB, Tech Transfer
Clinical Affairs Jobs
By ProKatchers LLC At West Sacramento, CA, United States

The Clinical Affairs Scientist I will support the Clinical Affairs team during Microbiology antimicrobial susceptibility testing (AST) clinical trials. The incumbent performs testing as defined ...

Regulatory Affairs Specialist Jobs
By Real Staffing At Irvine, CA, United States
Support 510(k) reviews (if sufficient experience)
Excellent verbal and written communication skills
Experience in a collaborative cross-functional development environment
Experience with FDA’s ecopy submission template a plus
Assist with 510(k) IDE drafting/compilation
Assist with 510(k) ecopy and submission
Regulatory Affairs Specialist, Copy Compliance
By BeneFit Cosmetics At , San Francisco, 94104, Ca $62,000 - $83,000 a year
Manage review of website product copy, PR copy, visual merchandising assets, videos, FAQ and toolkit copy for global compliance.
4 to 5 years’ experience in cosmetic regulatory affairs, specifically in identifying risk level of global cosmetic or OTC claims
Experience working with industry counterparts and trade associations
Clear verbal, reasoning, and written communication skills.
Skills at summarizing complex regulations in simple terms.
Strong partnership skills to analyse and problem-solve in team dynamic.
Regulatory Affairs Specialist Jobs
By CymaBay Therapeutics At Newark, CA, United States
BA/BS or equivalent education with 1-3 years of relevant experience in Regulatory Affairs or related area. Advanced degree desirable.
Knowledgeable of GCP requirements and FDA guidelines
Demonstrates strategic thinking skills, and has the ability to drive projects based on group objectives
Excellent writing and organizational skills, and an ability to generate clear, concise documents
Strong planning and multitasking skills.
Essential Functions and Job Responsibilities:
Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
International Regulatory Affairs Specialist
By Scholl's Wellness Company At Parsippany, NJ, United States

Seeking a part time International regulatory consultant to help manage International product registrations in select International markets Must be familiar with the International registration process ...

Regulatory Affairs Specialist Jobs
By Managed Staffing, Inc. At Austin, TX, United States
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
The job description is detailed below:
Duration: 1+ year with possibility of extension
5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances
Reinsurance Prudential And Regulatory Affairs Specialist
By Insight Global At New York, NY, United States
-knowledge and experience in the insurance sector
-prior experience as an insurance supervisor
-prior experience as an actuary, insurance contract lawyer, or consultant in the financial services
-prior experience in coordinating projects involving a wide array of stakeholders.
-prior experience on ESG or cyber matters.
-ability to navigate and understand prudential regulation and supervisory guidance applicable to the insurance sector
Quality And Regulatory Affairs Analyst - Genetics Clinical Trials
By Mount Sinai Health System At United States
Maintaining a working knowledge and thorough understanding of federal and institutional regulations and polices relating to human subjects research
2+ years of experience in clinical research
Experience using electronic regulatory platforms a plus
Experience with industry-sponsored clinical trials preferred
Conducting internal auditing and monitoring activities to ensure compliance with study protocols and applicable regulations
Assisting investigators and clinical research coordinators in preparing for site monitoring visits and audits
Regulatory Affairs Intelligence Specialist
By Abbott Laboratories At , Plymouth $56,700 - $113,300 a year
Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
Experience in program management a plus
Experience with document management systems a plus
EDUCATION AND EXPERIENCE YOU’LL BRING
Performs other related duties and responsibilities, on occasion, as assigned
Strong verbal and written communication skills · Strong attention to detail and organizational skills
Global Clinical & Regulatory Affairs Operations Coordinator
By Orion At , $28 an hour
Experience with vendor and supplier management and engagement
Experience with contract management systems for legal agreements and contracts
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Bachelor's Degree in Business Administration, Economics, or related field preferred or a combination of education and experience.
Experience working in a fast-paced remote environment preferred as well as experience working with highly matrixed global organizations
A minimum of 3 years' experience in clinical regulatory affairs highly preferred.
Regulatory Affairs Specialist Cmc
By Viatris At United States
Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.
Position functions autonomously and consults with departmental management on an as-needed basis.
Position is remote, but expected to be a normal office situation occurring during typical US business hours.
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Regulatory Affairs Specialist Jobs
By ICON At , Farmingdale, 11735
Experience in regulatory requirements in clinical phase of biologics drug development is a plus
Excellent written and oral communication skills
Strong technical writing and editing skills
Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
Initiate regulatory submission when required and support ICON team with Regulatory Inspections
Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
Sr. Regulatory Affairs Specialist
By Abbott Laboratories At , Des Plaines $71,300 - $142,700 a year
Interpret and apply regulatory requirements
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Principles and requirements of applicable product laws
Principles and requirements of promotion, advertising and labeling
Has broad knowledge of various technical alternatives and their potential impact on the business
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Regulatory Affairs Specialist Jobs
By Philips At , Cambridge
Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
Proficient knowledge of domestic and international standards
Experience in supporting international registrations and/or clinical investigations.
Experience with Software Medical Devices strongly preferred.
Proficient computer skills in Microsoft Office Suite
Read more about our employee benefits.
Specialist, Regulatory Affairs Jobs
By Edwards Lifesciences At ,
Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge of new product development systems
Ability to manage competing priorities in a fast paced environment
Regulatory Affairs Specialist Cmc
By Viatris At , Remote $41,000 - $93,000 a year
Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.
Position functions autonomously and consults with departmental management on an as-needed basis.
Position is remote, but expected to be a normal office situation occurring during typical US business hours.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Regulatory Affairs Specialist Jobs
By Verathon At , Bothell $89,500 - $138,600 a year
Manage regulatory release authorization process
Experience working in an FDA regulated company for medical device or pharma is preferred
2+ years’ experience in quality assurance or regulatory affairs is preferred
Previous experience in a position that required multi-department interactions
Able to manage time effectively
Develop and compile documentation in support of new registrations
Regulatory Affairs Specialist Jobs
By Medtronic At , Woburn
Assist in keeping company informed of regulatory requirements in the International Regions.
Host meetings with relevant R&D, Quality, Manufacturing facility, Marketing and Cross Functional Teams as needed to support global registration requirements.
Bachelor's degree with 2 years of regulatory affairs experience
An advanced degree with 0 years of regulatory affairs experience
3+ years of medical device regulatory affairs experience
Experience with international submissions and experience with the FDA

Are you looking for an exciting opportunity to join a dynamic team in the Clinical Regulatory Affairs field? We are looking for a Clinical Regulatory Affairs Specialist to join our team and help us ensure compliance with all applicable regulations. You will be responsible for preparing and submitting regulatory documents, tracking submissions, and providing regulatory support to internal and external stakeholders. If you are a detail-oriented professional with excellent communication and organizational skills, we want to hear from you!

Overview Clinical Regulatory Affairs Specialists are responsible for ensuring that clinical trials and other research activities comply with applicable regulations and standards. They work closely with clinical research teams to ensure that all regulatory requirements are met and that the research is conducted in an ethical and safe manner. Detailed Job Description Clinical Regulatory Affairs Specialists are responsible for ensuring that clinical trials and other research activities comply with applicable regulations and standards. They work closely with clinical research teams to ensure that all regulatory requirements are met and that the research is conducted in an ethical and safe manner. Clinical Regulatory Affairs Specialists are responsible for developing and maintaining regulatory strategies, preparing regulatory submissions, and providing regulatory guidance to clinical research teams. They also review and approve clinical trial protocols, analyze data from clinical trials, and provide regulatory advice to sponsors and investigators. Job Skills Required
• Knowledge of applicable regulations and standards
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong organizational and problem-solving skills
• Ability to manage multiple tasks and prioritize work
• Proficiency in Microsoft Office applications
Job Qualifications
• Bachelor’s degree in a related field
• At least two years of experience in clinical research or regulatory affairs
• Knowledge of applicable regulations and standards
• Understanding of clinical trial design and data analysis
• Ability to interpret and analyze clinical trial data
Job Knowledge
• Knowledge of applicable regulations and standards
• Understanding of clinical trial design and data analysis
• Knowledge of clinical research processes and procedures
• Knowledge of medical terminology
• Knowledge of Good Clinical Practice (GCP)
Job Experience
• At least two years of experience in clinical research or regulatory affairs
• Experience in preparing regulatory submissions
• Experience in reviewing and approving clinical trial protocols
• Experience in analyzing clinical trial data
Job Responsibilities
• Develop and maintain regulatory strategies
• Prepare regulatory submissions
• Provide regulatory guidance to clinical research teams
• Review and approve clinical trial protocols
• Analyze data from clinical trials
• Provide regulatory advice to sponsors and investigators
• Monitor clinical trials for compliance with applicable regulations and standards
• Ensure that research is conducted in an ethical and safe manner