Regulatory Specialist Salary at Memx Llc BETA

Regulatory Specialist/Compliance Manager The Regulatory Specialist/Compliance Manager must possess 3-5 years Clinical. Research Regulatory experience and the ability to work in a fast-paced Retina practice. Retina experience preferred. Bachelor's degree preferred Conduct study start-up activities Initial Application to IRB/Approval/Informed Consent Forms Complete 1572 Financial disclosure Forms Prepare all documents for SIV/Activation Create and keep all SSDLs Maintain necessary documents for compliance Maintain IRB access Maintain compliance of regulatory documents Prepare for internal/sponsor/FDA audits as applicable Maintain GCP and other regulatory training requirements Maintain Regulatory training logs i.e.: Protocol, IB, Procedure Manuals, eCRF Guidelines, Lab Manuals, BCVA Manuals, ECG Manuals, IWRS etc. Complete all vendor start-up documents/activities as applicable Maintain Compliance with PI and SI training, initial and ongoing Manage regulatory documents for close-outs IRB c

Position Overview: The Regulatory Specialist reports directly to the Vice President of Quality Control & Regulatory. This role involves independently managing customer requests and ensuring compliance with US and international regulations. Key Responsibilities: Prepare regulatory documentation, including certifications for natural products, allergens, FDA/FEMA-GRAS, food grade, GMO, BSE, pesticides, and heavy metals as well as country of origin, nutritional, and organic certifications Address customer inquiries in alignment with regulatory guidelines Manage company quality documentation, including vendor approvals Support audits (internal, customer, and regulatory agency) and special regulatory projects Collaborate with internal departments to fulfill customer requests Conduct thorough investigations into any issues that arise Qualifications: Bachelor's Degree in Food Science, Nutritional Sciences, Food Technology, Chemistry or a related field 3+ years of Regulatory work experience in

Responsibilities: The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Support the IA business units in meeting global registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Ensures timely preparation of organized and scientifically valid reports both internally and externally Coordinates and manages the post-market regulatory reporting and compliance activities in accordance with Company procedures and regulatory requirements. Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling reg

Job Description Job Description The Regulatory Specialist/Compliance Manager must possess 3-5 years Clinical Research and Regulatory experience and the ability to work in a fast-paced Retina practice. Retina experience preferred. Bachelor's degree preferred Conduct study start-up activities Initial Application to IRB/Approval/Informed Consent Forms Complete 1572 Financial disclosure Forms Prepare all documents for SIV/Activation Create and keep all SSDLs Maintain necessary documents for compliance Maintain IRB access Maintain compliance of regulatory documents Prepare for internal/sponsor/FDA audits as applicable Maintain GCP and other regulatory training requirements Maintain Regulatory training logs i.e.: Protocol, IB, Procedure Manuals, eCRF Guidelines, Lab Manuals, BCVA Manuals, ECG Manuals, IWRS etc. Complete all vendor start-up documents/activities as applicable Maintain Compliance with PI and SI training, initial and ongoing Manage regulatory documents for close-outs IRB close-o

Job Description This position of Regulatory Specialist reports directly to the Vice President of Quality Control & Regulatory. The individual will be responsible to independently work with customers and provide them with the necessary and requested regulatory information in accordance with customer specific guidelines and various US and international regulations. Job Responsibilities To independently prepare customer documentation to satisfy customer requests. This function requires knowledge of specific customer, US FDA Food/Flavor &State Regulations. Specific documents include: Natural Certification, FDA/FEMA-GRAS Certifications, Allergen Letters, Food Grade Certifications, GMO Certification, BSE, Pesticides and Heavy Metals Certifications, Continuing Food Guarantee, Country of Origin Certifications, Customer Questionnaires, Nutritional, Organic, Country Permissibility and other appropriate documents. Support the management in other regulatory tasks (including special projects) and i

Job Description The Quality and Regulatory Specialist facilitates and participates in the implementation of the multidisciplinary hospital and system wide Clinical Quality and Patient Safety Performance Improvement Program. This is a healthcare professional who coordinates the planning, monitoring and evaluation of the Quality and Regulatory Readiness program. Participates in planned and unplanned regulatory visit activity. Promotes collaborative practice among departments/services for improved clinical outcomes, processes of care and regulatory compliance. Responsibilities 1. Facilitates the identification of opportunities for improvement and assist in the design and ongoing measurement of performance indicators and outcomes as part of the Clinical Quality and Patient Safety Performance Improvement Program. 2. Assists in planning, reviewing, and implementing activities related to the organizational goals and objectives including Quality and Safety Goals. 3. Collaborates with key stake

Regulatory Affairs Specialist will play a critical role in protecting Mario Badescu Skin Care through balanced compliance and will manage all aspects of regulatory activities necessary to maintain and grow our business. This position is based in our Edison NJ location. Responsibilities: -Work with The Good Face Project screening software and our international team to ensure compliance with worldwide regulatory requirements. -Provide regulatory support for new product registrations, Certificates of Free Sale, labeling compliance, SDS authoring, PIF preparation per various international specific country registration requirements. -Develop and maintain procedures and systems to perform regulatory operational activities. -Implement regulatory strategies for launching new products and maintaining existing products. -Keep abreast of new regulatory changes in all target markets globally and new cosmetic regulations and guidelines and ensure adherence throughout the product life cycle. -Work c

Our client is looking to fill the role of Regulatory Affairs Specialist. The primary responsibility is writing regulatory submissions by successfully coordinating with the Regulatory Consultant and Management for priorities and deadlines; while maintaining compliance with cGMP requirements. Salary: $85-$90k Responsibilities: Interact with cross functional teams for procurement of documentation required for regulatory submissions. Review, manage and write regulatory submissions electronically which include New ANDA filings, Complete Response letters, Information requests, Amendments to the ANDA’s (Labeling, Chemistry & Bioequivalence) of different dosage forms (Liquid & Solutions, Others) Responsible for filing the Post Approval Supplements like CBE-0, CBE-30 (Changes being effective in 30 days) and Prior Approval Supplements (PAS) Review technical documents for accuracy and with supervision, determines acceptability for use in regulatory submissions (i.e. ANDA and NDA) Review of the le