Current jobs related to Senior Regulatory Affairs Specialist Consultant - Raritan - ClinChoice
-
Raritan, New Jersey, United States Johnson & Johnson Full timePosition Overview - Senior Vice President, Global Oncology Medical AffairsJohnson & Johnson is actively seeking a Senior Vice President for Global Oncology Medical Affairs. This pivotal role is designed to spearhead the strategic direction and execution of our Solid Tumor medical initiatives on a global scale.Company VisionAt Johnson & Johnson, we hold the...
-
Senior SAP SD Consultant
2 weeks ago
Raritan, New Jersey, United States Tata Consultancy Services Full timeJob Title: Senior SAP SD ConsultantJob Summary:We are seeking an experienced Senior SAP SD Consultant to join our team at Tata Consultancy Services. As a Senior SAP SD Consultant, you will be responsible for providing expert-level consulting services to our clients in the implementation and optimization of SAP SD solutions.Key Responsibilities:Implementation...
-
Senior SAP SD Consultant
1 month ago
Raritan, United States Tata Consultancy Services Full timeTitleSenior SAP SD ConsultantJob Responsibilities: Senior SAP SD Consultant Required Skills:9+ Years of experience as SAP SD Consultant. Should have minimum two End to End Implementation Experience.Should have good knowledge in OTC processes like Standard order, Consignment Process, Returns Process etc.Should have good Knowledge in Basic Functions of SAP...
-
Senior SAP S4 FICO Consultant
1 month ago
Raritan, United States Tata Consultancy Services Full timeTitleSenior SAP S4 FICO ConsultantJob Responsibilities: Senior SAP FICO Consultant Required Skills:15+ Years of experience as SAP FICO Consultant with hands-on experience in SAP S/4 Hana.Good to have hands-on experience in 2023 version of SAP S4 HANA FICOStrong experience in Supply chain Product Costing experienceStrong experience in Supply chain Finance...
-
Senior SAP S4 FICO Consultant
1 month ago
Raritan, United States Tata Consultancy Services Full timeTitleSenior SAP S4 FICO ConsultantJob Responsibilities: Senior SAP FICO Consultant Required Skills:15+ Years of experience as SAP FICO Consultant with hands-on experience in SAP S/4 Hana.Good to have hands-on experience in 2023 version of SAP S4 HANA FICOStrong experience in Supply chain Product Costing experienceStrong experience in Supply chain Finance...
-
Validation Specialist
2 weeks ago
Raritan, New Jersey, United States Tricon Solutions Full timeJob Summary:Tricon Solutions is seeking a highly experienced Validation Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our computer systems and processes.Key Responsibilities:Lead Validation Efforts: Guide project teams in the development and implementation of validation...
-
Senior Computer Systems Validation Specialist
2 weeks ago
Raritan, New Jersey, United States Cynet Systems Full timeJob Description:Cynet Systems is seeking a highly experienced Senior Computer Systems Validation Specialist to join our team.Key Responsibilities:Computer System Validation: Validate SAP system and other manufacturing systems.Regulated Industry Experience: Minimum 10 years regulated industry experience preferred with Computer System.Validation or Quality...
-
Computer System Validation Specialist
3 weeks ago
Raritan, New Jersey, United States Omni Inclusive Full timeJob DescriptionOmni Inclusive is seeking a highly experienced Computer System Validation Specialist to join our team. As a key member of our organization, you will be responsible for leading the validation of computer systems to ensure compliance with GxP regulations.Key Responsibilities:Lead Computer System Validation: Oversee the validation process for...
-
Senior Business Analytics Specialist
3 weeks ago
Raritan, United States QuidelOrtho Full timeThe Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with...
-
Senior Computer Systems Validation Specialist
3 weeks ago
Raritan, New Jersey, United States Cynet Systems Full timeJob DescriptionCynet Systems is seeking a highly experienced Senior Computer Systems Validation Specialist to join our team.Job Summary:We are looking for a seasoned professional with a strong background in computer systems validation to lead our validation efforts. The ideal candidate will have a deep understanding of GxP regulations and industry standards,...
-
Master Data Governance Senior Specialist
5 days ago
Raritan, New Jersey, United States Legend Biotech USA, Inc. Full timeJob Title: Master Data Governance Sr. SpecialistWe are seeking a seasoned Master Data Governance Sr. Specialist to lead the design and execution of our Materials orchestration strategy throughout the End-to-End Manufacturing & Supply lifecycle.Key Responsibilities:Develop and implement a comprehensive Master Data Governance framework to ensure data accuracy...
-
Senior R&D Engineer
16 hours ago
Raritan, New Jersey, United States J&J Family of Companies Full timeJob Title: Senior R&D EngineerWe are seeking a highly skilled Senior R&D Engineer to join our team at Mentor Worldwide LLC, a member of the J&J Family of Companies. As a Senior R&D Engineer, you will be responsible for leading and contributing to various cross-functional project teams, including R&D, manufacturing, marketing, and...
-
Senior Manager Supplier Quality
6 days ago
Raritan, New Jersey, United States J&J Family of Companies Full timeJob Title: Senior Manager Supplier QualityWe are seeking a highly skilled Senior Manager Supplier Quality to join our team at J&J Family of Companies. This role will be responsible for ensuring the quality of our suppliers and ensuring compliance with regulatory requirements.Key Responsibilities:Quality oversight of assigned suppliersRegulatory compliance...
-
Senior R&D Engineer
4 days ago
Raritan, New Jersey, United States J&J Family of Companies Full timeAbout the RoleWe are seeking a highly skilled Senior R&D Engineer to join our team at Mentor Worldwide LLC, a member of the J&J Family of Companies. As a Senior R&D Engineer, you will be responsible for leading and contributing to various cross-functional project teams, including R&D, manufacturing, marketing, and regulatory.Key ResponsibilitiesLead the...
-
Senior Financial Operations Specialist
3 weeks ago
Raritan, New Jersey, United States SEBCO Full timeJob OverviewThe Senior Financial Operations Specialist at SEBCO will play a crucial role in managing financial transactions and ensuring the integrity of our accounting processes.Key Responsibilities:Oversee the processing of monthly invoices across various company divisions, ensuring precise coding and entry into financial systems.Collaborate with the...
-
Laboratory Specialist
1 week ago
Raritan, New Jersey, United States Global Channel Management Full timeAbout the Job: Laboratory Specialist We are seeking a skilled Laboratory Specialist to join our team at Global Channel Management. As a Laboratory Specialist, you will play a critical role in ensuring the quality and accuracy of our laboratory testing processes. Responsibilities: * Conduct testing and analysis of Immunohematology products as part of a...
-
Senior Financial Operations Specialist
3 weeks ago
Raritan, New Jersey, United States SEBCO Full timeJob OverviewWe are seeking a Senior Financial Operations Specialist to manage and oversee our accounting processes at SEBCO. This role is pivotal in ensuring the smooth operation of our financial transactions and vendor relationships.Key Responsibilities:Handle the processing of monthly invoices across various company divisions, ensuring precise coding and...
-
Senior BY WMS Quality Assurance Specialist
4 weeks ago
Raritan, New Jersey, United States Cognizant Full timeCognizant is seeking to recruit a full-time resource for a permanent position as a Senior BY WMS Quality Assurance Specialist. The ideal candidate should possess 10-15 years of relevant experience. Location: Remote, USA Experience Required: 10+ Years About Us Cognizant stands as one of the foremost professional services firms globally,...
-
Senior R&D Engineer
1 week ago
Raritan, New Jersey, United States J&J Family of Companies Full timeAbout the RoleWe are seeking a highly skilled Senior R&D Engineer to join our team at Mentor Worldwide LLC, a member of the J&J Family of Companies. As a Senior R&D Engineer, you will be responsible for leading and contributing to various cross-functional project teams, including R&D, manufacturing, marketing, and regulatory.Key ResponsibilitiesLead the...
-
Validation Specialist
3 weeks ago
Raritan, New Jersey, United States Cynet Systems Full timeAbout the RoleCynet Systems is seeking a highly skilled Validation Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our computer systems.Key ResponsibilitiesComputer System Validation: Validate ERP to AWS Data migration process, Data migration project, and other related...
Senior Regulatory Affairs Specialist Consultant
4 months ago
at ClinChoice (View all jobs)
Raritan, New Jersey, United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....
ClinChoice is searching for a Senior Regulatory Affairs Specialist Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
POSITION SUMMARY
This position is open to candidates who have a minimum of 5 years of hands-on regulatory experience with US and EU Class III medical devices focusing on regulatory submissions and other relevant activities such as change assessments. This position requires a strong team player who can work across various cultures and departments to meet team, company, and client goals and assigned objectives.
Duties/Responsibilities:
Provide regulatory input and guidance during New Product Development and Lifecycle Management projects, including Regulatory strategy and supporting evidence including clinical data. Provide Regulatory assessments for new products and manufacturing/product changes (e.g. change orders) Define data and information needed for regulatory approvals of Class III US/EU medical devices and high-risk ROW. Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines; Prepare and submit regulatory submissions to FDA (e.g., 30-day notices, 135-Day Supplements, etc.,) and Notified Body (e.g. TD). Communicate, negotiate, and maintain rapport with the FDA and Notified Body reviewers to identify pre-submission requirements and ensure submission strategy alignment as needed. Prepare responses to Regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals. Provide Regulatory input and guidance to cross-functional teams. Partner with RA affiliates on submission pathways in their respective country as well as other functions to define and obtain data to assist with regulatory submissions. Review and assess Clinical reports as needed. Represent Regulatory Affairs and provide regulatory advice on cross-functional project teams. Plan schedules for regulatory deliverables on a project and monitor project through completion. Collaborate in the development and approval of labeling, after evaluating conformance to regulations. Review marketing material as needed. Guide conformance with applicable regulations in product development, support of claims and label content. Maintain various tracking tools to ensure up to date information and traceability of all regulatory data/documentation. Provide solutions to complex problems where analysis of situations or data requires an in-depth evaluation of multiple variables. Effectively communicate with internal and external teams and/or clients as to the status of deliverables to ensure timely and satisfactory completion of tasks and expectation. Perform other duties assigned as needed.
Experience/Skills
Minimum of 5 years of hands-on regulatory experience with US and EU Class III medical devices focusing on regulatory submissions and other relevant activities such as change assessments. Must have proven ability to prepare and submit Class III medical device submissions to FDA and Notified Body including assessments and submittal of product changes. Experience with FDA PMA regulations, EU MDD/MDR, ISO13485 and ISO14971. Experience in working with cross-functional teams on product development and manufacturing projects. Must possess excellent written and verbal communication skills. Proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint). Good understanding of current Good Documentation Practices in regulatory environment. Strong organizational skills including attention to detail, good planning and communication skills are required. Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation. or data requires evaluation of various factors with minimal supervision. Detail oriented with strong critical thinking and analytical skills and keen on producing results.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-PR1 #LI-Hybrid #Contract
