Senior Regulatory Affairs Specialist
5 days ago
At Terumo Blood and Cell Technologies, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a pivotal role in ensuring regulatory compliance and driving the success of our innovative medical products.
Key Responsibilities:- Develop strategic regulatory plans and expertly navigate submissions to ensure timely approval for market release.
- Collaborate cross-functionally to address challenges and seize opportunities, leveraging your in-depth knowledge of global medical device and pharmaceutical regulations.
- Review and analyze product labeling to ensure compliance with applicable US and international regulations.
- Negotiate and interact with regulatory agencies and certification authorities to ensure submission approval.
- Identify the need for new or modified regulatory procedures, SOPs, and participate in development and implementation.
- Bachelor's degree in physical/biological sciences or engineering, or equivalent experience.
- Seven (7) years' experience in Regulatory Affairs, or a mix of Regulatory and Quality experience in a regulated environment.
- Excellent written and verbal communication skills, with the ability to prioritize and handle several projects concurrently.
- Leadership and mentoring skills, with the ability to provide guidance and support to less experienced regulatory personnel.
- Regulatory Affairs Certification (RAC) preferred.
- A competitive total reward package, including salary, benefits, and recognition programs.
- A collaborative and dynamic work environment, with opportunities for growth and development.
- The chance to work on innovative medical products that make a real difference in people's lives.
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Regulatory Affairs Specialist
1 week ago
Lakewood, United States Terumo BCT Full timeJob Title: Principal Regulatory Affairs SpecialistTerumo Blood and Cell Technologies is seeking a highly skilled Principal Regulatory Affairs Specialist to lead our FDA, Health Canada, and/or EU MDR submissions process.Key Responsibilities:Develop and execute regulatory strategies to ensure successful approvals for our innovative healthcare...
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US Government Affairs Leader
2 weeks ago
Lakewood, United States Terumo BCT Full timeJob Title: US Government Affairs LeaderAt Terumo Blood and Cell Technologies, we are seeking a highly skilled US Government Affairs Leader to join our team. This role will be responsible for developing and executing the organization's government affairs strategy within North America.Key Responsibilities:Develop and implement a comprehensive government...
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US Government Affairs Leader
5 days ago
Lakewood, United States Terumo BCT Full timeJob Title: US Government Affairs LeaderAt Terumo Blood and Cell Technologies, we are seeking a highly skilled US Government Affairs Leader to join our team. This role will be responsible for supporting the development and execution of our government affairs strategy within North America.Key Responsibilities:Develop and implement a coherent government affairs...
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US Government Affairs Leader
5 days ago
Lakewood, United States Terumo BCT Full timeJob Title: US Government Affairs LeaderJob Summary:The US Government Affairs Leader will be responsible for developing and executing the organization's government affairs strategy within North America. This role will focus on building and maintaining relationships with political and policy stakeholders at the federal, state, and local levels.Key...
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US Government Affairs Leader
3 weeks ago
Lakewood, United States Terumo BCT Full timeGovernment Affairs & Public Policy Leader- North AmericaThe Government Affairs & Public Policy Leader- North America is responsible for supporting the development and execution of the organization's government affairs strategy within North America. This role focuses on building and maintaining relationships with political and policy stakeholders at the...
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Government Affairs and Public Policy Leader
4 weeks ago
Lakewood, United States Terumo BCT Full timeJob SummaryThe Government Affairs and Public Policy Leader will be responsible for developing and executing the organization's government affairs strategy within North America. This role will focus on building and maintaining relationships with political and policy stakeholders at the federal, state, and local levels.Key ResponsibilitiesDevelop and Execute...
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Senior Biocompatibility Specialist
3 weeks ago
Lakewood, United States Terumo BCT Full timeBiocompatibility Specialist Job DescriptionAt Terumo Blood and Cell Technologies, we are seeking a highly skilled Biocompatibility Specialist to join our team. As a Biocompatibility Specialist, you will play a critical role in ensuring the safety and efficacy of our medical devices and products.Key Responsibilities:Partner with manufacturing, engineering,...
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Senior Biocompatibility Specialist
2 weeks ago
Lakewood, United States Terumo BCT Full timeBiocompatibility Specialist Job DescriptionAt Terumo Blood and Cell Technologies, we are seeking a highly skilled Biocompatibility Specialist to join our team. As a Biocompatibility Specialist, you will play a critical role in ensuring the safety and efficacy of our medical devices and products.Key Responsibilities:Partner with manufacturing, engineering,...
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Senior Biocompatibility Specialist
4 months ago
Lakewood, United States Terumo BCT Full timeRequisition ID: 32107 At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our...
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Senior Environmental Engineer
4 weeks ago
Lakewood, United States Environmental Chemical Co Inc Full timeJob SummaryEnvironmental Chemical Co Inc is seeking a highly skilled Senior Environmental Engineer to join our team. As a Senior Environmental Engineer, you will be responsible for leading environmental remediation and hazardous waste management projects from conception to completion.Key ResponsibilitiesPlan, select, coordinate, and implement scientific and...
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Senior Microbiologist
3 weeks ago
Lakewood, New Jersey, United States Renaissance Lakewood LLC Full timeJob SummaryRenaissance Lakewood LLC is seeking a highly skilled Senior Microbiologist to join our Quality Control team. As a key member of our laboratory, you will be responsible for ensuring the quality and safety of our products through microbiological testing and analysis.Key ResponsibilitiesMicrobiological Testing: Conduct microbiological analysis on...
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Home Care Aide
4 weeks ago
Lakewood, United States Senior Helpers - Cerritos Full timeJob Summary:We are seeking a compassionate and reliable Home Care Aide to join our team at Senior Helpers - Cerritos. As a Home Care Aide, you will provide high-quality care and companionship to our clients in the comfort of their own homes.Responsibilities:Assist clients with daily activities, such as bathing, dressing, and groomingProvide transportation to...
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Senior Tax Compliance Specialist
1 month ago
Lakewood, United States Tallgrass Full timeJoin Our Team as a Senior Tax Compliance Specialist We are excited to present a fantastic career opportunity at Tallgrass Energy for a Senior Tax Compliance Specialist. In this pivotal role, you will play a crucial part in managing indirect tax obligations and strategic planning to contribute to our ongoing success. This position comes with a competitive...
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Strategic Government Relations and Policy Expert
4 weeks ago
Lakewood, United States Terumo BCT Full timeJob SummaryThe Government Affairs and Public Policy Leader is responsible for developing and executing the organization's government affairs strategy within North America. This role focuses on building and maintaining relationships with political and policy stakeholders at the federal, state, and local levels.Key ResponsibilitiesDevelop and Execute...
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Housekeeping and Caregiving Specialist
1 month ago
Lakewood, United States THE RISING SUN SENIOR HOME INC Full timeJob OverviewWe are seeking dedicated individuals for the role of Housekeeping and Caregiving Specialist. This position involves providing essential support in a residential setting, ensuring a clean and safe environment for our residents.Key ResponsibilitiesMaintain cleanliness and organization of living spaces.Assist residents with daily activities and...
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Licensed Practical Nurse
2 weeks ago
Lakewood, United States WestLake Care Community Full timeSenior Care Specialist OpportunityWe are seeking a compassionate and skilled Licensed Practical Nurse to join our team at WestLake Care Community. As a Senior Care Specialist, you will play a vital role in providing exceptional care to our residents and fostering a culture of person-centered care.About the RoleAs a Licensed Practical Nurse, you will be...
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Senior Commercial Banking Specialist
3 weeks ago
Lakewood, Ohio, United States First Mutual Holding Company Full timeJob SummaryThe Senior Commercial Banking Specialist is a senior member of the loan officer team responsible for commercial banking for companies up to $60 million in revenue. This role requires a high level of business development results, portfolio management, collaboration, and professional representation. The ideal candidate will have a strong...
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Nurse Specialist
2 weeks ago
Lakewood, California, United States Biolife Plasma Services Full timeAbout the RoleAs a Plasma Center Nurse at BioLife Plasma Services, you will play a vital role in ensuring the quality and safety of plasma donations. Your primary responsibility will be to determine donor eligibility, manage donor adverse events, and review laboratory test results. You will also be responsible for notifying donors of unsuitable test results...
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Nurse Specialist
2 weeks ago
Lakewood, California, United States BioLife Plasma Services Full timeAbout the RoleAs a Plasma Center Nurse at BioLife Plasma Services, you will play a vital role in ensuring the quality and safety of plasma donations. Your primary responsibility will be to determine donor eligibility, manage donor adverse events, and review laboratory test results. You will also be responsible for notifying donors of unsuitable test results...
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Strategic Government Relations
4 weeks ago
Lakewood, United States Terumo Blood and Cell Technologies Full timeJob SummaryThe Government Affairs & Public Policy Leader– North America is responsible for supporting the development and execution of the organization's government affairs strategy within North America. This role focuses on building and maintaining relationships with political and policy stakeholders at the federal, state, and local levels.Key...