Regulatory Compliance Operations Specialist
3 weeks ago
Job Summary
We are seeking an experienced Regulatory Compliance Operations Specialist to join our team at Linda Werner & Associates. As a key member of our Legal & Compliance Team, you will play a vital role in ensuring the company's compliance and facilitating readiness for key legal and regulatory requirements.
The ideal candidate will have 10+ years of relevant experience in consulting, strategy, operations, or equivalent program management experience, with a particular focus on legal & compliance. You will be responsible for setting goals and executing strategy as a business owner for core legal & compliance operational workflows, measuring effectiveness via metrics and key performance indicators.
This is a contract position for 6 months, working onsite in MPK/SF/NYC/ATL. The expected hours are 40 per week, with benefits including dental insurance, health insurance, health savings account, life insurance, paid time off, retirement plan, and vision insurance. A salary of $120,000 - $150,000 per year is estimated based on location and industry standards.
Key Responsibilities:
- Set goals and execute strategy as a business owner for core legal & compliance operational workflows.
- Measure effectiveness via metrics and key performance indicators.
- Track resourcing and capacity, and monitor the overall health of the program.
- Build out and strengthen operational processes and systems.
- Program manage opportunities, foresee challenges, predict roadblocks, strengthen cross-functional relationships, and execute plans.
- Ideate and inform the development of team goals.
- Work with team members on strategies for executing, measuring progress, and sharing results that enable the team to identify efficiency gains and improvements.
Minimum Qualifications:
- 10+ years of relevant experience in consulting, strategy, operations, or equivalent program management experience.
- Effective critical thinking and experience leveraging data to anticipate and unblock problems and drive solutions.
- Experience in the Legal, Public Policy, or Regulatory space (including operations, audit, control/safeguard management, etc.).
- Proven time-management and organizational skills.
- Experience working with teams to develop and improve operational systems and tools.
- Experience driving collaboration of cross-functional teams, coordinating effectively, and inspiring others.
-
Healthcare Regulatory Compliance Lead
1 day ago
Menlo Park, California, United States Aerotek Full timeJob DescriptionAerotek is seeking a Compliance Manager - EH&S to lead the integration of solutions that address multiple regulatory requirements and certifying agencies, ensuring compliance with rules affecting safety, security, hazardous waste, medical equipment, fire/life safety, and utilities.Main ResponsibilitiesManage daily regulatory compliance,...
-
Regulatory Compliance Specialist
3 weeks ago
Baldwin Park, California, United States Ihealth Labs Inc Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at iHealth Labs Inc. in Sunnyvale, California.This role will be responsible for overseeing the development and implementation of regulatory strategies for medical devices, ensuring compliance with ISO 13485, FDA, and MDR/IVDR regulations.The ideal candidate will have a...
-
Director of Compliance and Regulatory Strategy
24 hours ago
Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full timeKey ResponsibilitiesProvide regulatory guidance on project teams and key sub-teams at study levelAssess, develop, and implement competitive global regulatory strategies for ivonescimab, identifying potential risks and mitigation steps with proposed strategiesOwn regulatory activities at molecule and study-level, including clinical trial application (CTA) and...
-
Regulatory Compliance Coordinator
3 weeks ago
Baldwin Park, California, United States Professional Search Group - Orange County Full timeJob Title: Regulatory Compliance CoordinatorProfessional Search Group - Orange County is seeking a highly skilled Regulatory Compliance Coordinator to join their team. The successful candidate will support the Environmental and Regulatory Department for our client by ensuring compliance with environmental regulations.Job Summary:The Regulatory Compliance...
-
Menlo Park, California, United States Linda Werner & Associates Full timeAbout the RoleWe are seeking a skilled Legal & Compliance Process Improvement Specialist to join our team at Linda Werner & Associates. As a key member of our Legal & Compliance Team, you will be responsible for driving process improvement initiatives and developing operational systems to deliver efficient reporting, innovative risk mitigation, and...
-
Global Regulatory Specialist
3 weeks ago
Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full timeRegulatory Affairs OpportunityWe are looking for a highly motivated Senior Associate to join our regulatory affairs team. The ideal candidate will have a strong background in regulatory affairs and experience working with global regulatory agencies.Key Responsibilities:Support processes by which regulatory submissions are reviewed, finalized, and...
-
Regulatory Affairs Director
2 months ago
Menlo Park, California, United States Lifelancer Full timeLead Regulatory Affairs efforts for Orca Bio, a late-stage biotechnology company developing cell therapies.The ideal candidate will have 12+ years of regulatory experience, including 8+ years in leadership within the biotech/pharmaceutical industry or as a seasoned regulator.We offer a competitive salary range of $180,000 - $250,000 based on prior...
-
Senior Regulatory Specialist
24 hours ago
Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full timeWhat We're Looking ForBA/BS degree in the biological or health-related sciences required; graduate-level degree a plusRelevant bio-pharmaceutical industry experience, including a minimum of 5+ years of experience in regulatory affairsKnowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and...
-
Compliance Operations Strategy Lead
3 weeks ago
Menlo Park, California, United States Linda Werner & Associates Full timeCompliance Operations Strategy LeadLinda Werner & Associates is seeking an experienced Compliance Operations Strategy Lead to join our team in MPK, SF, NYC, or ATX. As a key member of our Legal & Compliance Team, you will be responsible for developing and implementing strategic plans to drive compliance and operational excellence.The ideal candidate will...
-
Regulatory Affairs Specialist
3 weeks ago
Baldwin Park, California, United States Ihealth Labs Inc Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at iHealth Labs Inc.The ideal candidate will have a strong understanding of regulatory frameworks in the US, EU, and China, and be able to communicate effectively with regulators to obtain pre-market approval/clearance.Key ResponsibilitiesDevelop and implement...
-
Compliance Manager
1 day ago
Menlo Park, California, United States Aerotek Full timeJob SummaryThis Healthcare Regulatory Compliance Lead position requires a strong understanding of regulatory requirements and certification agencies, with a focus on ensuring compliance with rules affecting safety, security, hazardous waste, medical equipment, fire/life safety, and utilities.ResponsibilitiesEnsure daily regulatory compliance through regular...
-
Product Compliance Specialist
6 days ago
Newbury Park, California, United States Randstad North America, Inc. Full timeWe are seeking a highly motivated Product Compliance Specialist to join our team at Randstad North America, Inc. in Thousand Oaks, CA. As a key member of our team, you will support the product complaint s Quality Assurance department in ensuring compliance with regulatory requirements.">The ideal candidate will have experience in quality assurance and a...
-
Senior Compliance Operations Project Manager
3 weeks ago
Menlo Park, California, United States Linda Werner & Associates Full timeJob OverviewLinda Werner & Associates is seeking an experienced Senior Compliance Operations Project Manager to join our team in MPK, SF, NYC, or ATX. As a key member of our Legal & Compliance Team, you will be responsible for setting goals and priorities for core operational workflows, measuring their effectiveness via metrics and key performance...
-
Quality Control and Compliance Lead
2 days ago
Menlo Park, California, United States CSBio Full timeJoin Our TeamCSBio is a dynamic and innovative company committed to delivering high-quality compounds to research organizations and pharmaceutical companies worldwide. We are seeking a Quality Assurance Specialist to join our team and contribute to our mission of excellence.About the RoleAs a Quality Assurance Specialist, you will be responsible for...
-
Menlo Park, California, United States Aerotek Full timeJob OverviewAerotek is seeking a highly skilled Environmental Health and Safety Specialist to join our team. This role will lead the integration of solutions that address multiple regulatory requirements and certifying agencies, ensuring compliance with rules affecting safety, security, hazardous waste, medical equipment, fire/life safety, and utilities.Key...
-
Privacy Compliance Architect
1 day ago
Menlo Park, California, United States Robinhood Full timeYour RoleIn this key role, you'll direct the selection and implementation of privacy-enhancing technologies (PETs) that align with our privacy strategy and contribute to the robustness of our data protection efforts. You'll also evaluate emerging privacy technologies, frameworks, and regulatory requirements, including potential impact on our privacy strategy...
-
Compliance Operations Specialist
24 hours ago
Menlo Park, California, United States Rose International Full timeAbout Rose InternationalRose International is a leading provider of specialized staffing solutions, delivering top talent to clients across various industries. Our team is dedicated to helping clients achieve their goals through strategic partnerships and expert recruitment.
-
Audit and Compliance Expert
1 day ago
Menlo Park, California, United States Aston Carter Full timeJoin Our TeamAston Carter is seeking a talented Internal Auditor III to join our team. In this role, you will have the opportunity to work on challenging projects and contribute to the success of our organization.Responsibilities:Conduct thorough audits to ensure the integrity of our internal controls and processes.Develop and maintain expertise in industry...
-
Chief Corporate Compliance Officer
5 days ago
Menlo Park, California, United States Exponent Full timeExponent, a leading engineering and scientific consulting firm, seeks an experienced Corporate/Privacy Attorney to join its legal team in Menlo Park, CA.About ExponentWe empower our clients with innovative solutions to their most complex challenges. With a multidisciplinary team of experts, we tackle the toughest science and engineering questions, ensuring...
-
Medical Device Regulatory Lead
3 weeks ago
Baldwin Park, California, United States Ihealth Labs Inc Full timeAbout the RoleiHealth Labs Inc. is seeking a seasoned Regulatory Compliance Specialist to join our team in Sunnyvale, California.In this critical role, you will be responsible for developing and implementing regulatory strategies for medical devices, ensuring compliance with relevant regulations and industry standards.The ideal candidate will have a strong...