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- Los Angeles, CA
new job!

Regulatory Affairs Project Manager Job – Medical DeviceOur client needs a Regulatory Affairs Project Manager to support Asia Pacific (Japan, China, South Korea and Taiwan) regulatory approvals for implantables. Comfort and experience working hands on with design and validation reports and other technical files is needed.RequirementsPrevious experience authoring or approving design and validation reports a plus (strong technical writing skills).Experience in Regulatory Affairs with US Class III


The company is a leading, privately held national food service company serving business and industry, education, healthcare and the entertainment sectors with on-site dining, catering, vending and beverage services. RESPONSIBILITIES: Primary point of contact for all quality assurance and food safety related topics and company liaison to clients and regulatory agencies for safety inquiries, issues and concerns. Process and standards expert responsible for initiatives, development, improvement,....

- Elmsford, NY
new job!

Senior Clinical Trials Project Manager Elmsford, NY or Glasgow, DE (Relocation Provided) Competitive Pay, Bonus, 4 weeks PTO, 6% 401K, Great benefits We have a new opening for a Senior Clinical Project Manager with a longstanding client; a multi-billion ($8B+) global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that impact people's lives. A lot

- East Hanover, NJ

To be considered for this position you must have at least 7 or more years of regulatory affairs experience in the area of In Vitro Diagnostics (IVD) along with hands-on preparation of 510K submissions for IVD products. Strongly prefer someone form the medical device industry (not pharmaceutical mfg). Any experience dealing with face-2-face meetings with regulators (like Pre-Submission meetings) will be considered a valuable asset. Provide regulatory strategies for products, including....

- Hopkinsville, KY

Our Food Safety Manager is responsible for managing our in-house Micro-Lab and implementing and managing process control systems and preventative actions in the food safety area. You will manage all HACCP and Regulatory compliance issues at this processing site. Client company cannot sponsor or transfer Visa's at this time. Qualifications:Bachelor’s degree in Food Science, Microbiology, Chemistry, Biology. An advanced degree is preferred.A minimum of five years’ experience in Food Safety....


QUALITY ASSURANCE MANAGER Our QA Manager is responsible for leading the Plant Quality and Sanitation teams directing the daily operations of the Quality Assurance and Sanitation function to uphold company policies, formulas, specifications and regulatory requirements, as well as ensures that all finished product meets food safety and quality standards. Requirements:Bachelor's degree in Food Science, Chemistry, Biology, Microbiology or a related discipline.Certifications in SQF, HACCP, and....

- Richmond, VA

Our client is looking for a EHS Manager/Product Safety Manager to join their team. The company is stable, profitable, and expanding quickly through 2018. The EHS Manager will be responsible for developing and implementing policy and strategic plans for company environmental, health and safety affairs. Job Responsibilities:Lead plant Safety program and enhance plant safety cultureIdentify and manage common EHS compliance issuesManage all workers compensation claims and other EHS....


Join a global leader as a Ph.D. Toxicologist responsible for conducting quantitative risk assessments for agrichemical and fertilizer products and traits in North America. You will provide technical advice on study designs for regulatory and research oriented studies as well as advice to support new and existing registrations of client products and traits. --- Work closely with regional/global regulatory and product safety teams as well as other functional teams to produce risk assessments for


Director of Quality Microbiology To build and run a new fully compliant QA department for a cGMP sterile 503B manufacturing facility. Key responsibilities:Implement and ensure compliance with US Food, Drug &Cosmetic Act, 21 CFR parts 210 and 211 Section 503A and 503B, and all its related elements such as facilities, documentation (SOPs and validation protocols, etc.), training, reports and recordsManage 503B facility chemistry and microlab for end product testing and environmental....

- San Francisco, CA

Our client needs a MSL with Dermatology experience who lives in the San Francisco, CA area to cover the Northwest geography. Education and Experience - Advanced degree with health science background (Pharm.D, M.D., Ph.D, preferred) - Preferred minimum 3 year total specific industry experience (pharma, device, etc) and minimum 4 years post professional degree practice or relevant transferable experience (clinical practice, academic research, regulatory/scientific) - Experience in Medical....


Key Responsibilities:Coordinate, assemble and/or prepare for submission various materials to the FDA such as ANDAs/supplements, periodic reports for approved products. Assist VP to lead all interactions with regulatory agencies.Point of contact to local regulatory authorities and maintain the communication system.Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams.To have overall....

- Cincinnati, OH

Job Description: Responsibilities include supporting daily compliance and systems activities. Performs audits (internal and vendor audits), supports change control program, complaints and any customer services related to Documentation Center. Also works with manufacturing to identify resolution to events while working with Quality Management. The candidate will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving....

- Newark/Princeton Area, NJ

Our client, a Fortune 150 Medical Diagnostics Equipment Manufacturer, is looking for a Senior QA Auditor to join Division Team in Central New Jersey area and independently conduct assigned audits to assess compliance to applicable business/division requirements, external standards/regulations and Corporate Quality System requirements across multiple Plants within Division. Participate in audits of manufacturing and commercial affiliate sites.in US and CanadaManage and/or participate in....


Well-established Pharmaceutical Manufacturer is undergoing a dynamic growth initiative in Research and Development (R&D). As part of this expansion, we are searching for a Quality Director for R&D. The Quality Director, R&D, will be responsible for the overall leadership and execution of Quality Assurance programs and policies across the R&D functions, including BioClinical Development, Pharmacovigilance, Regulatory and Medical Affairs, and Product Development (Generics and....

- Kansas City, KS

RETAINED SEARCH ASSIGNMENT Title: VP or Dir Regulatory Affairs Excellent opportunity ... Great Culture ... Good Benefits ... Fast Growing Company ... Companion Animal Products. Areas of experience required: Prior Animal Health Reg Affairs, Pre- Approval & Post Approval Submissions, FDA, CVM, AHI, Pharmacovigilance (MUST have Post Approval) Our client will consider a virtual office with required trips to the home office. Please only candidates interested and qualified need apply. All CV /....

- York, SC

The incumbent in this position will be responsible for developing and evaluating silicone materials to meet Customer and Market needs in the Sealing and Bonding Market for electronics, mold making and other related applications. The incumbent will conduct studies and carry out trials for research, development and continuous reliability of the products and formulations. The primary function will be to formulate silicone based products supporting strategic business markets. Key activities will....

- Indianapolis, IN

TITLE: Blood Bank Administrator LOCATION: Indianapolis, IN Are you considering a career change? Would you be interested in living in a large city that doesn't feel like it. The Indianapolis area has something for everyone. If so, an opportunity to work an established organization that serves several locations in Indiana is looking for someone to join their team. Summary The Blood Bank Network Administrator assists in development of data-driven pre-analytical, analytical, and post-analytical....


Assoc Dir, Toxicology Top tier global pharmaceutical company and a leader in a new industry model – Growth Pharma focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. Company markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic

- Irvine, CA, CA

Non-Clinical Study Monitor Global pharmaceutical company and a leader in a new industry model – Growth Pharma. Company is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. Offices all over the US- but this opening is for their Northern New Jersey location (commutable to NYC, on PATH line) Global markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care,

- West Los Angeles area, CA

Growing Oncology Clinical Trial site in the west side of Los Angeles has an opening for a Regulatory (IRB) Associate. This is a contract position while the incumbent is on maternity leave. Responsibilities:Will provide support for clinical research protocols, informed consents, etc.Will assist with all aspects of clinical research regulatory to ensure compliance to regulations and protection of human subjectsPrepare and submit documents to the IRBRequirements:Bachelor's degree required1+....

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