Current jobs related to Regulatory Specialist - Los Angeles - Rishabh RPO
-
Regulatory Affairs Specialist
1 month ago
Los Angeles, California, United States BioPhase Solutions Full timeJob Title: Regulatory Affairs SpecialistBioPhase Solutions is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Coordinate and prepare document packages and dossiers for regulatory...
-
Regulatory Affairs Specialist
3 weeks ago
Los Angeles, California, United States BioTalent Full timeRegulatory Affairs SpecialistBioTalent is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a critical role in ensuring our medical devices comply with global regulations.Key Responsibilities:Develop and implement regulatory strategies to obtain timely approvals from worldwide...
-
Regulatory Affairs Specialist
4 weeks ago
Los Angeles, United States BioTalent Full timeRegulatory SpecialistMy client is seeking a Regulatory Specialist to join our growing team. As a Regulatory Specialist, you will play a crucial role in ensuring our medical devices comply with global regulations.Key Responsibilities:Develop and implement regulatory strategies to obtain timely approvals from worldwide regulatory bodies.Prepare and submit...
-
Regulatory Affairs Specialist
3 weeks ago
los angeles, United States BioTalent Full timeRegulatory SpecialistMy client is seeking a Regulatory Specialist to join our growing team. As a Regulatory Specialist, you will play a crucial role in ensuring our medical devices comply with global regulations.Key Responsibilities:Develop and implement regulatory strategies to obtain timely approvals from worldwide regulatory bodies.Prepare and submit...
-
Regulatory Affairs Specialist
2 weeks ago
Los Angeles, California, United States BioPhase Solutions Full timeJob Title: Regulatory Affairs SpecialistBioPhase Solutions 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 ensuring compliance with global regulatory requirements for medical devices.Key Responsibilities:Coordinate and prepare document packages and dossiers for...
-
Regulatory Affairs Specialist
2 weeks ago
Los Angeles, California, United States IntelliPro Group Inc. Full timeJob Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at IntelliPro Group Inc. This role will be responsible for ensuring compliance with regulatory standards for medical devices, including Class I, II, and III devices.Key Responsibilities:Collaborate with cross-functional teams to...
-
Regulatory Compliance Specialist
1 month ago
Los Angeles, California, United States Kitsch LLC Full timeJob Title: Regulatory Compliance SpecialistKitsch LLC is seeking a highly skilled Regulatory Compliance Specialist to join our Quality team. As a key member of our team, you will be responsible for ensuring that our products comply with regulatory requirements in all sales markets.Key Responsibilities:Conduct product evaluation and specify regulatory...
-
Regulatory Compliance Specialist
2 weeks ago
Los Angeles, California, United States Kitsch LLC Full timeJob DescriptionWe are seeking a highly skilled Regulatory Compliance Specialist to join our Quality team at Kitsch LLC. The ideal candidate will have a strong understanding of global cosmetic laws and regulations, as well as experience in quality assurance and regulatory compliance.The successful candidate will be responsible for ensuring that our products...
-
Regulatory Compliance Specialist II
2 months ago
Los Angeles, California, United States L.A. Care Health Plan Full timeJob SummaryThe Regulatory Compliance Specialist II is responsible for ensuring the Customer Solution Center's readiness for regulatory audits. This position will develop a comprehensive auditing strategy for end-to-end processes, including enrollment processing, member interactions, and service authorization requests. The Specialist will also be responsible...
-
Healthcare Regulatory Specialist
2 weeks ago
Los Angeles, California, United States Top Tier Reps LLC Full timeJob OverviewTop Tier Reps LLC is seeking a highly motivated and detail-oriented professional to join their team as a Healthcare Regulatory Specialist. This role will involve working on complex Medicaid-related projects, collaborating with cross-functional teams, and providing strategic counsel on regulatory and compliance matters.Key ResponsibilitiesDevelop...
-
Regulatory Compliance Specialist
1 week ago
Los Angeles, California, United States Thrive Causemetics Full timeJob Summary:The Regulatory Compliance Specialist will play a critical role in ensuring that all Thrive Causemetics products comply with local, national, and international regulatory standards.This position involves a blend of regulatory knowledge and quality control expertise to maintain the highest standards of product safety, efficacy, and compliance.The...
-
Regulatory Affairs Specialist
2 weeks ago
Los Angeles, California, United States IntelliPro Group Inc. Full timeJob OverviewIntelliPro Group Inc. is seeking a highly skilled Regulatory Affairs Specialist to oversee medical device development and market introduction, ensuring compliance with regulatory standards for Class I, II, and III devices.This role involves collaborating with cross-functional teams to conduct regulatory pre- and post-market analyses, preparing...
-
Regulatory Relations Specialist
1 week ago
Los Angeles, California, United States City National Bank Full timeJob SummaryCity National Bank is seeking a highly skilled Regulatory Relations Specialist to join our team. As a key member of our regulatory relations team, you will be responsible for coordinating end-to-end regulatory activity within the bank and the broader Combined US Operations (CUSO) from receipt of first day letter through remediation and closure.Key...
-
Regulatory Compliance Specialist II
2 weeks ago
Los Angeles, California, United States L.A. Care Health Plan Full timeJob SummaryThe Regulatory Compliance Specialist II is responsible for ensuring the Customer Solution Center (CSC) is ready for regulatory audits. This position will develop a successful auditing strategy for end-to-end processes within CSC, including enrollment processing, timeliness and accuracy of loading members, and outbound health risk assessment calls....
-
Regulatory Affairs Specialist
1 week ago
Los Angeles, California, United States Medtronic Full timeJob SummaryMedtronic is seeking a highly skilled Regulatory Affairs Specialist to join our team in the Diabetes business. As a key member of our global regulatory strategy and advocacy team, you will be responsible for developing and refining fit-for-purpose regulatory strategies to support innovations in the Diabetes business.Key Responsibilities:Develop...
-
Clinical Research Coordinator
1 week ago
Los Angeles, California, United States Amerit Consulting Full timeJob Title: Clinical Research Coordinator - Regulatory SpecialistJob Summary:Amerit Consulting is seeking an experienced Clinical Research Coordinator - Regulatory Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs and clinical trials, with a proven track record of success in coordinating studies and ensuring...
-
Assistant General Counsel
2 weeks ago
Los Angeles, California, United States ACC - Association of Corporate Counsel Full timeRegulatory Compliance SpecialistChildren's Hospital Los Angeles (CHLA) is seeking a highly skilled Regulatory Compliance Specialist to join its Office of the General Counsel. The ideal candidate will have a strong understanding of healthcare regulatory landscapes and experience providing clear, practical guidance in structuring transactions, policies, and...
-
Regulatory Affairs Operations Specialist II
2 weeks ago
Los Angeles, California, United States Abbott Laboratories company Full timeJob SummaryAbbott Laboratories is seeking a highly skilled Regulatory Affairs Operations Specialist II to join our team in Sylmar, CA. As a key member of our regulatory operations team, you will be responsible for ensuring compliance with regulatory agency specifications and supporting product market entry.Key ResponsibilitiesPrepare Global Trade Services...
-
Regulatory Affairs Strategist
2 weeks ago
Los Angeles, California, United States Randstad Full timeJob Title: Regulatory Affairs SpecialistAt Randstad, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing worldwide regulatory programs for marketed products and those in development.Key Responsibilities:Develop and implement worldwide...
-
Regulatory Affairs Expert
1 week ago
Los Angeles, California, United States Astrix Full timeAstrix is seeking a skilled Regulatory Affairs Specialist to join their team in Los Angeles. As a key member of the biopharma industry, this role will play a crucial part in developing regulatory processes for pharmaceutical products.Key Responsibilities:Collaborate with cross-functional teams to create and implement regulatory strategies.Provide expert...
Regulatory Specialist
2 months ago
Location- 2410 Lillyvale Avenue, Los Angeles, CA (Remote)
Start Date:09/09/2024 End Date:02/08/2025Hours Per Day: 4.00Hours Per Week: 20.00Job Description
Summary:
Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements.Job Duties:
Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products
Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.
Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.
Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.
Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.
Writes documents with complex scientific information for regulatory submissions. JobRequirements:
Bachelor's Degree in a related scientific discipline with at least 4+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry.
Knowledge and understanding of FDA and EU regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations.
Excellent oral and written communication skills. Critical thinking and problem-solving skills. Demonstrated project management skills.
Ability to interact with regulatory officials.
Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives.
Ability to work within a global team framework and multi-cultural environment.
Ability to write comprehensive scientific information for use in regulatory submissions to the FDA and EU.
Ability to manage multiple complex projects and timelines in a matrix team environment.
Demonstrated interpersonal skills including negotiation.
Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines.
Leadership skills within a matrix driven organization.
