- Spectraforce Technologies Inc (Bridgewater, NJ)
- …out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or ... response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she performs life… more
- Stryker (Mahwah, NJ)
- …our award-winning organization by visiting stryker.com We are currently seeking a **Senior Regulatory Affairs Specialist ** to join our Joint Replacement ... **What you will do** As the **Senior** **R** **egulatory Affairs Specialist ** , you will evaluate the regulatory environment providing internal advice… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …Responsible for US change control assessment for assigned products. + Manage regulatory affairs activities including preparation of Annual Report, Change Control ... required, and the role will collaborate with tasks across the existing US Regulatory Affairs team Education/Experience: + BS/BA/MS degree in science. Minimum of… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …diagnostics and those of associated disciplines (such as R&D, Regulatory Affairs , Quality Assurance, or Project Management). The Specialist , Medical ... **Job Description Summary** The Specialist , Medical Affairs for Post-Market Surveillance...timelines and workload demands, and are in compliance with regulatory requirements + Asserts own ideas and persuades others.… more
- Balchem (Montvale, NJ)
- Senior Scientist - Corporate Regulatory Affairs Department: Legal/ Regulatory Location: Montvale, NJ Start Your Application ... excellent internal customer service. Provide expert guidance to internal stakeholders on regulatory affairs as they relate to Balchem- s product lifecycle… more
- AbbVie (Florham Park, NJ)
- …County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and scientific strategic and ... operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of clinical and scientific… more
- Novo Nordisk (Princeton, NJ)
- …to Management in ROI and works cross-functionally with internal departments on Regulatory Affairs related issues. Essential Functions + With direction from ... living. Are you ready to make a difference? The Position The Specialist , Regulatory Operations - Submissions supports the development of submission plans created… more
- Stryker (Mahwah, NJ)
- …Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory ... is available at www.stryker.com We are currently seeking a **Staff Regulatory Compliance Specialist ** to join our Joint Replacement Division based hybrid in… more
- Stryker (Mahwah, NJ)
- …required; preferably with medical devices. + A minimum of 2 years in a Regulatory Affairs role required. + Strong interest in medical science, clinical research, ... at www.stryker.com We are currently seeking a **Staff** **Clinical Evaluation Specialist ** join the **Clinical Affairs ** , **Joint Replacement** **Division,**… more
- Merck (Rahway, NJ)
- **Job Description** The Senior Professional Services Veterinarian- Dermatology Specialist will function to support the commercial, medical, and business needs of the ... may include, but are not limited to: + Utilizes specialist knowledge and experience in dermatology to serve as...leaders of diverse expertise and backgrounds, and assist medical affairs in developing and guiding advisory boards + Represent… more
- J&J Family of Companies (Trenton, NJ)
- …UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party ... Clinical Safety Specialist - 2406185254W **Description** Abiomed, part of Johnson...DSMB/DMC preferred * Experience with complaint handling, quality & regulatory processes preferred * Strong interpersonal skills and well-developed… more
- Organon & Co. (Jersey City, NJ)
- …interfaces include sites, External manufacturing, Quality Ops, Product Development groups, Regulatory Affairs , Procurement and suppliers. Knowledge of design ... Internal Manufacturing Sites, Contract Manufacturers, Analytical Testing, Quality Assurance, and Regulatory Affairs . + Provide direction for selecting new… more
- Meta (Trenton, NJ)
- …to Job" online on this web page. **Required Skills:** Community Escalations Specialist , Risk and Response Responsibilities: 1. Interpret and enforce company terms of ... the most sensitive and complex escalations of public interest involving regulatory and legal requests to resolution, and communicate to cross-functional partners.… more
- Medtronic (NJ)
- **Careers that Change Lives** The Neurovascular **Associate Training and Education Specialist ** will assist in the development and execution of Neurovascular Health ... interaction and communication with the Sr. Manager of Medical Education, Medical Affairs , Marketing, internal business partners, and Field Sales Leaders. You will… more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Specialist leverages their regulatory ... pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in… more
- Army National Guard Units (Sea Girt, NJ)
- … SPECIALIST , GS-0671-9, you will: Review, evaluate, and interpret regulatory guidance, policies and procedures Responsible for oversight, administration, and ... This National Guard position is for a HEALTH SYSTEMS SPECIALIST , Position Description Number D1119000 and is part of...implement of policies pertaining to state medical affairs Provide guidance to all users through development of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …such as Formulation and Process Development, MSAT, Manufacturing, Engineering, and Regulatory Affairs to ensure that Clinical/Commercial Drug Substance/Drug ... **Job Description** **Role and Responsibilities:** Gilead Sciences is looking for a QA Specialist I, for the position of Quality Operational Lead, to join our… more
- NJ Transit (Newark, NJ)
- …service. + Acts as official liaison with Department of Transportation (DOT) office of regulatory affairs on fleet safety and regulatory compliance. Serves as ... unsafe for public use. + Directs and controls the Quality Assurance and regulatory compliance functions of the NJ TRANSIT bus fleet, Contracted Services (Access… more
- Hackensack Meridian Health (Neptune, NJ)
- …+ Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field ... compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …BD products in partnership with other BD functions including Quality and Regulatory Affairs + Support clinical safety data inquiries/Health Authority Responses ... safety oversight and collaborative relationship with the BD Business Unit (BU) Medical Affairs . This role is a function of the centralized BD Global Medical Safety… more
