Full-Time Regulatory Affair Specialist jobs
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REGULATORY AFFAIRS SPECIALIST I
Collaborate with local and international colleagues to generate high quality submissions to obtain drug and/or medical device approvals in target markets. Gather design and development information on products from cross-functional...
| Company | Fresenius Kabi Ag |
|---|---|
| Address | Lake Zurich, IL |
| Category | Information Technology |
| Job type | Full-Time |
| Date Posted | 3 weeks ago See detail |
Regulatory Affairs Specialist I
Fresenius Kabi Ag
Lake Zurich, IL
Collaborate with local and international colleagues to generate high quality submissions to obtain drug and/or medical device approvals in target markets. Gather design and development information on products from cross-functional...
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Regulatory Affairs Specialist
Argen Corporation
San Diego, CA
Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. Our Awesome Benefits!Working for a growing innovative compa...
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Research Regulatory Specialist III New
Adventhealth Orlando
Orlando, FL
$29.46 - $44.19 an hour
Benefits from Day One. Paid Days Off from Day One. Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando. Serves as the major tertiary facility for much of the Southeast, the Caribbean and South...
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Regulatory Affairs Specialist
Redbock- An Nes Fircroft Company
Remote
$70.9K - $89.8K a year
Prepare and maintain international submission dossiers. Prepare electronic pre-market and post-market regulatory submissions. Compile Technical Documentations for IVD medical devices. Monitor progress on project deliverables and p...
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Regulatory Affairs Specialist
Brs
Remote
$62.1K - $78.7K a year
Contractor shall have at least 5 years experience applying FDA research regulatory requirements within a research Regulatory Affairs program office. Work in preparing ones own research proposals and ones own submissions to an IR...
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Sr. Regulatory Affairs Specialist
Oxenham Group Llc
Saint Paul, MN
Writing and updating technical files to meet applicable regulatory requirements, to included Essential Requirements, General Safety and Performance Requirements, Device classification, compiling technical documentation, identifica...
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Principal Regulatory Affairs Specialist
Vertos Medical, Inc
Aliso Viejo, CA
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Mental Demand Moderate to high degree of concentration due to volume, complexity, and/or pressure of work. Abil...
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Staff/Principal Regulatory Affairs Specialist (Operations)
Recor Medical
Palo Alto, CA
Manages post market activities, including but not limited to EU MDR and MEDDEV compliant Clinical Evaluation documents for new products and maintain/update existing company Clinical Evaluation Plans (CEPs), Clinical Evaluation Rep...
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Senior Regulatory Affairs Specialist
Iconma, Llc
Saint Paul, MN
This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...
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Senior Regulatory Affairs Specialist
Axelon
Saint Paul, MN
This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...
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Regulatory Affairs Specialist
Teleflex
Chelmsford, MA
$90,000 - $110,000 a year
Obtain timely market authorizations for Interventional products. Ensure regulatory requirements are met for quality systems, labeling, and promotional materials. Assess the impact of proposed regulations and guidance documents on...
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Regulatory Affairs Specialist
Cybotic System
Ithaca, NY
Up to $80,000 a year
Remain current on all applicable regulatory guidances that impact the companys ability to legally market medical devices around the world and assist in updating relevant SOPs based on those changes. Remain current with all mandat...
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Sr. Regulatory Affairs Specialist
Organ Recovery Systems, Inc.
Itasca, IL
From $90,000 a year
401(k). 401(k) matching. Dental insurance. Employee assistance program. Flexible schedule. Flexible spending account. Health insurance. Life insurance. Paid time off. Professional development assistance. Tuition reimbursement. Vis...
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CAREER OPPORTUNITY FOR YOU! Senior Regulatory Affairs Specialist
Techlink Systems
Temecula, CA
Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in. Have working knowledge in US and EU medical device submissions. Have experience supporting internal and external inspections Work cross-f...
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Regulatory Affairs' Specialist
Partners Personnel
Los Angeles, CA
Qualifications Discretion in handling confidential and sensitive information. Knowledge of Good Manufacturing Practices and regulations from the FDA, CMS, and Federal Trade Commission (FTC). Understanding of pharmaceutical and...
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Senior Regulatory Affairs Specialist
Pulmonx Corporation
Redwood City, CA
Provides regulatory input and technical guidance on global regulatory requirements to product development teams. Advises stakeholders of regulatory requirements for quality, preclinical and clinical data to meet applicable regulat...
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Senior Regulatory Affairs Specialist
Ultimate Staffing Services
Irvine, CA
Regulatory affairs experience with Class II and III medical devices. Outside of the US experience is preferred on top of domestic experience, specifically the EU.. Proven track record of developing written RA plans & strategies.....
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Sr. Specialist, Regulatory Affairs CMC
Biospace
United States
Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...
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Specialist - Regulatory Affairs
Biospace
Plainsboro, NJ
Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...
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Senior Associate - Regulatory Affairs New
Biospace
Princeton, NJ
Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...
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Senior Regulatory Affairs, Study Start Up Specialist
Cti Clinical Trial Services Inc
Covington, KY
$73K - $92.5K a year
Perform/ oversee compliance assessments against Food and Drug Administration (FDA) lists and documents any FDA activity discovered; notifies Study Manager of any FDA activity documented per CTI SOPs. Compile/ oversee site Regulato...
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System Management & Regulatory Specialist
Pseg
Newark, NJ
Ensure proper execution of technical controls associated with regulatory compliance programs including NERC CIP, SOX, BPU and FERC Affiliate Restrictions. Manage patching cycles for workstations and servers associated with Securit...
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Senior Manager, Regulatory Affairs Vendor Governance
Biospace
California, United States
Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...
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Regulatory Affairs Manager (CMC Site)
Biospace
New Albany, OH
Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...
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Regulatory Specialist
Zeon Chemicals Inc
Louisville, KY
Processing customer inquiries regarding regulatory affairs and product safety. Review of raw material and acquisition of relevant regulatory documents from vendors. Preparation of declarations of conformity:Product formulary discl...
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Manager, Global Regulatory Affairs CMC
Biospace
Boston, MA
I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...
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Regulatory Compliance Data Integrity Specialist, Senior
Agc Biologics
Longmont, CO
Provide guidance for implementation of site procedures regarding validation requirements for e-systems to ensure they comply with regulatory requirements for DI. Ensure risk-based methodologies for the assessment of computer syste...
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Regulatory Affairs Consultant
Katalyst Healthcares And Life Sciences
Rahway, NJ
Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...
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Regulatory Affairs Consultant
Katalyst Healthcares & Life Sciences
Rahway, NJ
Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...
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Counsel, Head of Global Regulatory Affairs
An Asset Management Company
Los Angeles, CA
Coordinate TCW's engagement with regulators and other policymakers on Global Regulatory matters, including representing TCW in such engagements. Position TCW to influence policy and regulations; consider TCW's clients and business...
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