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Specialist - Regulatory Affairs
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Novo Nordisk Plainsboro, United States**About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...
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Regulatory Affairs Specialist Ii
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Katalyst Healthcares & Life Sciences Inc Edison, United States**Responsibilities**: · - This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of pr ...
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Sr. Regulatory Affairs Specialist
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ClinChoice Raritan, United StatesJob Title: Senior Regulatory Affairs Specialist · Employment Type: Full Time or 1 year Contract with potential extension · Location: Raritan, NJ (Selected candidate should be able to work 3 days every week at Raritan, NJ office). · We are looking for Candidates with Proven experi ...
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Regulatory Affairs Specialist
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Brenntag Iselin, United StatesStage Picture:brenntag_other_8.jpgJobTitle:Regulatory Affairs Specialist - PharmaLocation:South Plainfield/USAEmployment Type:EmployeeRegulatory Affairs Specialist - PharmaOur team in South Plainfield currently has an opening for a Regulatory Affairs Specialist - PharmaYOUR ROLE ...
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Specialist - Regulatory Affairs
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Novo Nordisk A/S Plainsboro, United StatesProvide proactive support and technical assistance to more experienced regulatory personnel. Identify issues and inform appropriate individuals. Ability to work with less supervision than Associate. Take initiative to assist with overflow in other ar Regulatory Affairs, Regulator ...
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Regulatory Affairs Specialist
2 days ago
Brenntag Iselin, United StatesStage Picture: · JobTitle: · Regulatory Affairs Specialist - Pharma · Location: · South Plainfield/USA · Employment Type: · Employee · Regulatory Affairs Specialist - Pharma · Our team in · South Plainfield · currently has an opening for a · Regulatory Affairs Speciali ...
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Regulatory Affairs Specialist
2 days ago
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Regulatory Affairs Specialist
1 week ago
Katalyst Healthcares and Life Sciences South Plainfield, United StatesResponsibilities: Provides administrative support for regulatory affairs manager · Provides RA support for change control projects and sustaining activities · Conducts regulatory assessments and determines need for re-registration for proposed device changes, prepares internal ...
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Regulatory Affairs Specialist
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Reliance Private Label Supplements Edison, United StatesJob Description · Job DescriptionPOSITION SUMMARY: · Responsible for all aspects of the documentation process including the label/supplement facts panel (SFP) development, review and implementation of dietary supplement labels for private label, branded and contract formulations ...
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Regulatory Affairs Specialist
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Adecco Morris Plains, United StatesAdecco Creative and Marketing is partnering with an American multinational beauty company. We are searching for a Compliance Analyst for a 6 month hybrid assignment in Morris Plains, NJ. This person would be responsible for cosmetic regulatory compliance on the global team. · Job ...
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Specialist - Regulatory Affairs
4 days ago
Novo Nordisk Plainsboro, United StatesAbout the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to ...
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Specialist - Regulatory Affairs
4 days ago
Novo Nordisk Plainsboro, United StatesAbout the DepartmentThe Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to prov ...
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Specialist - Regulatory Affairs
1 week ago
Novo Nordisk Plainsboro, United States Full timeAbout the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to ...
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Regulatory Affairs Specialist
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Katalyst HealthCares & Life Sciences Short Hills, United StatesResponsibilities:Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reportsExperienced in authoring of assessment reports and Part2/ Expert reports for DossiersExperience in reviewing of quality documents such ...
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Regulatory Affairs Specialist
2 weeks ago
Adecco Morris Plains, United StatesAdecco Creative and Marketing is partnering with an American multinational beauty company. We are searching for a · Compliance Analyst · for a 6 month hybrid assignment in Morris Plains, NJ. This person would be responsible for cosmetic regulatory compliance on the global team. ...
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Regulatory Affairs Specialist
5 days ago
Katalyst HealthCares & Life Sciences Short Hills, United StatesResponsibilities: · Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports · Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers · Experience in reviewing of quality do ...
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Regional & Community Affairs Specialist
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Con Edison Staten Island, United StatesRegional & Community Affairs Specialist · Job Info · 112202 · Posting Expiration Date:Jun 30, 2024 · Schedule Type:Full-Time · Minimum Salary:$80000 · Maximum Salary:$100000 · Organization:Government Regional& Comm Affs · Department:NYC Regional&Community Affairs · Section:REG CO ...
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Regulatory Affairs Staff Specialist
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Stago Parsippany, United StatesSummary: Ensures compliance with regulations and guidelines set by the US FDA. Specifically for Hemostasis IVD tests and laboratory instrumentation, which are used for patient clinical evaluations. Ensures that the Hemostasis instrumentation and diagnostic tests meet all applicab ...
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National Guard Employment Network Staten Island, United StatesJob Description · ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spou ...
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Manager, Due Diligence Quality
2 days ago
Dow Jones Princeton, United StatesDow Jones is looking for a Quality Manager to join our Due Diligence team responsible for the creation of high-quality reports on companies and/or individuals using a combination of publicly-available sources and proprietary databases. As a Quality Manager, you will be responsibl ...
Senior Regulatory Affairs Specialist - Raritan, United States - ClinChoice
1 week ago
Description
Job Title: Senior Regulatory Affairs Specialist
Employment Type: Full Time or 1 year Contract with potential extension
Location: Raritan, NJ (Selected candidate should be able to work 3 days every week at Raritan, NJ office).
We are looking for Candidates with Proven experience in regulatory affairs in Class III medical devices and PMA submissions in this position.
ClinChoice is a global CRO that offers high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.
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.
Main Job Tasks and 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.
Education and Experience:
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.
ClinChoice is an Equal Opportunity Employer / Committed to Diversity
