Current jobs related to Regulatory Affairs Specialist - Trenton - Terumo Cardiovascular Group
-
Regulatory Affairs Team Leader
2 weeks ago
Trenton, New Jersey, United States Englewood Lab Full timePosition OverviewAs a Regulatory Affairs Team Leader, you will play a pivotal role in guiding and developing a team of Regulatory Affairs Associates. Your expertise will be essential in navigating complex regulatory landscapes and ensuring compliance across various domains.Key Responsibilities1. **Team Leadership**: Mentor and supervise a dedicated team,...
-
Regulatory Affairs Manager
2 weeks ago
Trenton, New Jersey, United States Stiftung Nv Full timeAre you passionate about fostering relationships across various levels of an organization? If you are a self-driven individual with resilience and the ability to prioritize tasks effectively, we invite you to consider a role as a Regulatory Affairs Manager within our esteemed team.About the RoleAs a key member of our Regulatory Interface and External...
-
Senior Regulatory Affairs Leader
2 weeks ago
Trenton, New Jersey, United States Atlas Search Full timeAbout the RoleAtlas Search is collaborating with a prominent biopharmaceutical organization in search of a skilled Senior Regulatory Affairs Leader. This position presents a remarkable chance to shape global regulatory frameworks for their cutting-edge pharmaceutical offerings.The annual base salary for this role is positioned between $140,000 and $170,000,...
-
Regulatory Affairs Leader
2 weeks ago
Trenton, New Jersey, United States Haleon Full timePosition Overview:The US Regulatory Lead for Rx to OTC Transition plays a pivotal role within the North American Regulatory Affairs Leadership Team (NA RALT). This position is integral in providing specialized support to the Rx to OTC Transition team and is directly responsible for overseeing all regulatory elements associated with the US Transition...
-
Senior Manager, Regulatory Affairs Strategy
2 weeks ago
Trenton, New Jersey, United States Moderna Full timePosition Overview:Moderna Therapeutics is on the lookout for a Senior Manager of Regulatory Affairs Strategy to join our dynamic team. This pivotal role is designed for an innovative and adaptable regulatory professional who can foresee and tackle the complexities associated with securing market authorization for cutting-edge messenger RNA therapeutics.Key...
-
Regulatory Affairs Manager/Senior Manager
2 weeks ago
Trenton, New Jersey, United States Gan & Lee Pharmaceuticals Ltd Full timePosition OverviewThis role is pivotal within Gan & Lee Pharmaceuticals Ltd, reporting directly to the Head of Global Regulatory Affairs. The selected candidate will play a crucial role in formulating and executing regulatory strategies, collaborating closely with cross-functional asset teams to prepare, review, and submit regulatory documentation....
-
Lead Manager for CMC Regulatory Affairs
2 weeks ago
Trenton, New Jersey, United States Regeneron Pharmaceuticals Full timePosition Overview: The selected candidate will spearhead the regulatory frameworks for biologic and combination products within the designated product portfolio.Key Responsibilities:Oversee CMC/CP product development initiatives, ensuring regulatory compliance during early phases, submissions, and post-market obligations.Engage in cross-functional IOPS...
-
Compliance and Regulatory Specialist
1 week ago
Trenton, New Jersey, United States Biogensys Full timeJob OverviewBiogensys is seeking a Compliance and Regulatory Specialist to join our dynamic team.Position Summary:In this role, you will operate under guidance to provide housing-related support and serve as a conduit between the Housing Division and the Regulatory Services department, facilitating requests for legal insights on behalf of the...
-
Sr. Manager, Regulatory Operations
2 weeks ago
Trenton, United States Proclinical Staffing Full timeSr. Manager, Regulatory Operations Management- Contract - New JerseyProclinical is seeking a dedicated and detail-oriented individual for the role of Sr. Manager, Regulatory Operations and Submission Management. This remote contract position will lead regulatory operations activities and manage US and global submissions for the Regulatory CMC group. Primary...
-
Sr. Manager, Regulatory Operations
2 weeks ago
Trenton, United States Proclinical Staffing Full timeSr. Manager, Regulatory Operations Management- Contract - New JerseyProclinical is seeking a dedicated and detail-oriented individual for the role of Sr. Manager, Regulatory Operations and Submission Management. This remote contract position will lead regulatory operations activities and manage US and global submissions for the Regulatory CMC group. Primary...
-
Executive Director, Global Clinical QA
2 weeks ago
Trenton, United States Proclinical Staffing Full timeExecutive Director of Global Clinical Quality Assurance - Permanent - NJProclinical is seeking a dedicated and innovative Executive Director to head up the department of Global Clinical Quality Assurance. Primary Responsibilities:The successful candidate will be required to lead the global quality assurance strategy, ensuring compliance with Good Clinical...
-
Executive Director, Global Clinical QA
2 weeks ago
Trenton, United States Proclinical Staffing Full timeExecutive Director of Global Clinical Quality Assurance - Permanent - NJProclinical is seeking a dedicated and innovative Executive Director to head up the department of Global Clinical Quality Assurance. Primary Responsibilities:The successful candidate will be required to lead the global quality assurance strategy, ensuring compliance with Good Clinical...
-
Lead Medical Information Specialist
7 days ago
Trenton, New Jersey, United States Inizio Engage Full timeJoin Inizio Engage as a Lead Medical Information SpecialistInizio Engage collaborates with a prominent Biotechnology firm, specializing in Commercial, Patient Solutions, and Medical Affairs sectors.The Lead Medical Information (MI) Specialist is responsible for developing and executing content across various channels within specific therapeutic areas,...
-
Dental Specialist
2 days ago
Trenton, New Jersey, United States DCS Clinical Full timeJob OverviewAt DCS Clinical, we are seeking a highly skilled and compassionate Oral Health Care Provider to join our team of dedicated professionals. As a key member of our dental care team, you will be responsible for delivering exceptional patient care and contributing to the overall success of our practice.Key Responsibilities:Diagnose and Treat Oral...
-
Program Specialist
20 hours ago
Trenton, New Jersey, United States NJ Department of Environmental Protection Full timeJob SummaryWe are seeking a highly skilled Program Specialist to join our team at the NJ Department of Environmental Protection. As a Program Specialist, you will play a critical role in supporting the planning, operation, and implementation of human or social service programs, as well as regulatory programs designed to ensure public safety, health, and...
-
Trenton, New Jersey, United States SMC Corporation Full timePosition OverviewThe Senior Vice President of Global Quality and Compliance will spearhead and enhance regulatory adherence and quality assurance strategies throughout the organization, ensuring cohesive alignment with corporate quality standards across all global sites. This pivotal role will act as a key collaborator and strategic partner across various...
-
Cost Estimation Specialist
2 weeks ago
Trenton, New Jersey, United States Real Talk Group Full timeCost Estimation Specialist Position - Join Our Innovative TeamOverviewAre you a detail-oriented and skilled Cost Estimation Specialist eager to engage in challenging construction initiatives? Do you excel in a dynamic atmosphere and possess a commitment to precision in heavy civil construction? If this resonates with you, we invite you to consider joining...
-
Schedule Specialist
1 month ago
Trenton, United States LHC Group Full timeSummary The Scheduling Specialist is responsible for managing patient referrals and visit schedules. Assigns patient assessments and other visits as ordered by the physician using an online scheduling system. Collaborates with the Team Leader to identify clinicians with the appropriate experience and skill set to match patient...
-
Executive Director, Global Clinical QA
1 week ago
Trenton, New Jersey, United States Proclinical Group Full timeExecutive Director of Global Clinical Quality AssuranceProclinical Group is seeking a dedicated and innovative Executive Director to lead the department of Global Clinical Quality Assurance.Key Responsibilities:Develop and Implement Quality Assurance StrategiesDevelop and implement global quality assurance policies and procedures that comply with Good...
-
Regional Sales and Operations Specialist
2 weeks ago
Trenton, New Jersey, United States JC Ehrlich Full timeJoin Our Team as a Regional Sales and Operations Specialist At JC Ehrlich, we are proud to be recognized as a Top Workplace. Our Regional Sales and Operations Specialist role offers benefits starting from day one for full-time colleagues, ensuring a seamless transition into our team. About Us JC Ehrlich is a leader in the pest control industry, dedicated to...
Regulatory Affairs Specialist
2 months ago
Press Tab to Move to Skip to Content Link
Select how often (in days) to receive an alert:
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next
Advancing healthcare with heart
This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements. Determining strategy and requirements within the position will vary in complexity based on scope and different regulatory markets. This position will prepare documents and/or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. Serves as a liaison between Regulatory Agencies and Terumo Medical Corporation. Mistakes made in this area can be very costly, i.e., delays in product clearance or approval withdrawal of product from the marketplace, or enforcement of fines. Any of the above would have a major impact on the corporation.
Associate is responsible to follow requirements of applicable national and international regulations.
Analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution.
Participates on product design teams and verifies compliance with design control requirements and procedures.
Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities.
Maintain documentation and a historical record for projects and provide management with updated product status.
Maintains current knowledge of Federal USA, Canadian, MDR and other International regulations pertaining to legal distribution of medical products. Stays abreast of Regulatory Agency updates including new policies and guidance’s.
Interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels with guidance.
Assists external customers by supplying materials and documentation for US and International product registrations as well as certification of appropriate US commercialization status.
Must make a proactive contribution to the overall Regulatory affairs department growth.
Participates in project performance team meetings on behalf of the business unit in order to provide ideas, methods or processes for unit/company performance improvement.
Develop regulatory strategies for new products with the guidance of Regulatory Management
Performs other job related duties as assigned.
Knowledge, Skills and Abilities (KSA)
Strong organizational skills and time management skills
Knowledge of GLP/GMP requirements
Strong written and oral communication skills
Knowledge of FDA, EU, MHLW, TGA and other International requirements
Knowledge of product labeling requirements and standards
Advanced ability for independent work, teamwork, and decision making
Ability to make correct decisions based on interpretations of federal laws, which in many instances are very general in nature to accommodate a variety of industries. These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues.
Ability to analyze data received and prepare documentation for submissions for the purpose of obtaining clearance and or approval for product distribution.
Qualifications/ Background Experiences
Requires a minimum of a 4-year degree in engineering, life sciences, or similar discipline and one year of relevant experience or combination of equivalent education, background, experience and training
Experience in a medical device quality assurance environment preferred
Experience with 510(k)/IDE/PMA device submissions and/or other worldwide submissions and clearances preferred.
Experience with FDA requirements, guidance documents, Medical Device Directive, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards preferred.
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
#J-18808-Ljbffr