- Houston Methodist (Houston, TX)
- At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific ... time management are important in the success of this position. The Sr Regulatory Compliance Specialist position maintains documentation for clinical research… more
- Catalent Pharma Solutions (Somerset, NJ)
- **Position Summary:** Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Regulatory Affairs Group. ... The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in...Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health… more
- Amazon (Sunnyvale, CA)
- …as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. ... regulatory timelines. * Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during … more
- System One (Somerset, NJ)
- Title: Sr. Compliance and Regulatory Specialist Location: Somerset NJ Schedule M-F 8:30 to 5:00pm On site daily Duration: 3 month contract to hire Education: ... least 5+ years of experience working in the pharmaceutical industry in Quality/ Regulatory Compliance , Quality Assurance, Quality Management Systems or associated… more
- LSI Solutions (Victor, NY)
- …state-of-the-art devices. After all, our customer is ultimately the patient. JOB TITLE: Regulatory Specialist (Labeling) - Days 8:00AM to 5:00PM SALARY RANGE: ... at LSI Solutions in Victor, NY JOB SUMMARY: The Regulatory Specialist applies her/his experience, knowledge, organization...and revised product lines, while maintaining full Quality and Regulatory compliance with all standards that govern… more
- Adecco US, Inc. (Swiftwater, PA)
- …registrations in existing markets. The Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance for marketed products by ... MSAT and GRA. . The Regulatory CMC Specialist will ensure Regulatory compliance ...CMC topics, as well as North American, European and International regulations/guidelines * Ability to manage multiple priorities efficiently… more
- Integra LifeSciences (Braintree, MA)
- … submissions. + Aid Supervisor in the development of US and International regulatory strategies and verification and validation activities for assigned ... advertising material for adherence to approved product claims and regulatory compliance . + Work in partnership with...+ Coordinate rollouts of product changes with corporate and international regulatory teams. + Coordinate Unique Device… more
- Florida Crystals Corporation (Boca Raton, FL)
- …Development, Quality, Legal, Marketing, Operations, Packaging and others, to ensure product compliance . The Regulatory Affairs Specialist provides updates on ... This position is responsible for assisting with matters involving the company's regulatory initiatives and regulatory compliance , specifically relating to… more
- Abbott (Pleasanton, CA)
- …products. + Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives. ... female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Heart Failure Division… more
- Abbott (Sylmar, CA)
- …employees, customers, contractors, and vendors. + Provides mentoring and leadership to Regulatory Specialist I and II team members **Required Qualifications** + ... location in Sylmar, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Specialist ** with our Cardiac Rhythm Management division. This… more
- Abbott (Irving, TX)
- …the core functional product team. + Participate in risk benefit analysis for regulatory compliance . + Assess the acceptability of quality, preclinical and ... Park, IL** currently has an opportunity for a **Senior Regulatory Affairs Specialist .** **What You'll Work On**...requirements. + Assist with label development and review for regulatory compliance before release. + Review product… more
- AdventHealth (Orlando, FL)
- ** Regulatory Specialist II: AdventHealth Orlando** **All the benefits and perks you need for you and your family:** - Benefits from Day One - Paid Days Off from ... outpatients each year **The role you'll contribute:** The Research Regulatory Specialist II, provides regulatory ...research staff to facilitate protocol adherence, patient safety, and regulatory compliance . Provides timely follow up on… more
- Arkema (King Of Prussia, PA)
- International Account Specialist Job Location: King of Prussia, PA, United States Employment Type: Regular Category: Customer Service Posting Date: Oct 25, 2024 ... The International Account ...team, interfacing with plants/shipping locations, Logistics, Credit, Accounts Receivable, Regulatory , and other Bostik departments. This position operates in… more
- AdventHealth (Orlando, FL)
- ** Regulatory Specialist I - AdventHealth Orlando** **All the benefits and perks you need for you and your family:** - Benefits from Day One - Paid Days Off from ... 125,000 outpatients each year **The role you'll contribute:** The Regulatory Specialist I, provides regulatory ...research staff to facilitate protocol adherence, patient safety, and regulatory compliance ._ _Provides timely follow up on… more
- Medtronic (Lafayette, CO)
- …development and review process + Provide business and product information to the international regulatory affairs team to enable development and strategies and ... compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible...+ Review promotional and advertising material + Maintain current regulatory knowledge of domestic and international regulations,… more
- Stryker (San Jose, CA)
- …+ Determines requirements (local, national, international ) and options for regulatory submission, approval pathways, and compliance activities + Provides ... changes to determine global regulatory impact, and completing actions to maintain regulatory compliance . + Assesses regulatory intelligence to assist in… more
- Stryker (Mahwah, NJ)
- …global regulatory impact assessments, and complete change tasks + Support international submissions and international regulatory notifications + Perform ... regulatory agencies and notified bodies. The Senior Regulatory Affairs Specialist is the Regulatory...file updates, NC/CAPA, and audits + Assist in developing regulatory strategy, approval pathways, and compliance activities… more
- Abbott (Plymouth, MN)
- …Think analytically with good problem-solving skills. + 510(k), PMA, or other international regulatory submission experience. + RAPS Certification. Apply Now ... their lives. **The Opportunity** We are recruiting for a ** Regulatory Affairs Specialist III** to join our...of product and teams as well as prepare US/CE regulatory submissions and/or registration documents for international … more
- Dana-Farber Cancer Institute (Boston, MA)
- …development and/or conduct of FDA regulated research from an operational and regulatory compliance perspective. These positions currently support 25 research ... The Regulatory Affairs Specialist (RAS) positions provides...critical to successfully achieving ongoing clinical research expansion and regulatory compliance at DFCI. **The selected candidate… more
- Actalent (Hackensack, NJ)
- … Regulatory Specialist Job Description The Regulatory Specialist is responsible for promoting compliance with Federal Regulations, Good Clinical ... Practice (GCP), and Institutional policies. The Regulatory Specialist will serve as a liaison...templates and site-level Informed Consent Forms (ICF) to ensure compliance with GCP and International Conference on… more
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