Regulatory Affair Specialist jobs
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SENIOR REGULATORY AFFAIRS SPECIALIST (ROBOTICS & DIGITAL SOLUTIONS) - ETHICON, INC.
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| Company | Johnson & Johnson |
|---|---|
| Address | Santa Clara, CA |
| Category | Sales/marketing |
| Date Posted | 2 days ago See detail |
Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc.
Johnson & Johnson
Santa Clara, CA
...
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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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Sr. Regulatory Affairs Specialist - Cardiac Diagnostics CDx
Boston Scientific
Hills, MN
Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices. Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, inc...
5 days ago seen See more...
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Principal Regulatory Affairs Specialist (medlance.co)
Medlance
Remote
$30 - $300 an hour
Lead regulatory strategy development for medical device projects. Manage submissions to regulatory bodies. Advise on regulatory requirements and changes. Collaborate with cross-functional teams for regulatory compliance. Extensive...
2 weeks ago seen See more...
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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...
2 weeks ago seen See more...
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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...
2 weeks ago seen See more...
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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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Senior Regulatory Affairs Specialist
Collabera
Saint Paul, MN
Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - suppliers should use: Plan and prepare documents for EU MDR Technical File original submiss...
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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...
3 weeks ago seen See more...
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Regulatory Affairs Specialist II
Bausch + Lomb
Remote
$65,000 - $95,000 a year
Responsible for general knowledge of pharmaceutical, consumer and medical device regulations in Regional and Local markets. Partners closely with cross-functional stakeholders to document registration strategy and implementation p...
3 weeks ago seen See more...
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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...
3 weeks ago seen See more...
Senior Regulatory Affairs Specialist
Collabera
Temecula, CA
Must have 1-3 years of experiences in Medical Device Regulatory Affairs. Skills: Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in Have working knowledge in US and EU medical device submiss...
a month ago seen See more...
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Product Safety and Regulatory Affairs Specialist, Automotive and Specialty Coatings
Akzonobel
Troy, MI
Maintain working knowledge of North America regulations that impact Automotive and Specialty Coatings for the United States, Canada, and Mexico. Ensure data integrity and accuracy of data sources. Will support the maintenance of...
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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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Senior Regulatory Affairs Specialist (LC 6103)
Techdata Service Company Llc
Irvine, CA
Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory...
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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.....
a month ago seen See more...
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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Regulatory Affairs Specialist II
Cypress Hcm
Fort Worth, TX
Provide regulatory support for Bio-Rad products that will be transitioning from the IVDD to IVDR CE Marking. Collaborate with cross-functional groups (e.g., Quality Assurance, Research & Development, Marketing) to collect and coor...
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Regulatory Affairs Specialist - Fort Worth TX
Advantage Technical
Fort Worth, TX
Able to work with minimal supervision. Strong customer orientation and focus. Able to work independently and with others. Education: Bachelors degree or equivalent in Biology, Chemistry, Medical Technology, or related field. Work...
2 months ago seen See more...
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24-9 Regulatory Affairs Specialist
Siertek Ltd
Remote
$70.7K - $89.5K a year
Employee shall provide expert technical research FDA-related regulatory review of others research proposals and be of the kind and sufficient experience that would enable the contractor to independently provide critical guidance...
2 months ago seen See more...
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Regulatory Affairs Specialist II – APAC - Diabetes Care
Abbott Laboratories
Alameda, CA
$73,600 - $147,200 a year
Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer con...
2 months ago seen See more...
- View all Abbott Laboratories jobs - jobs in Alameda, CA
Regulatory Affairs Specialist I
Quintalent Inc
Hercules, CA
$35 - $40 an hour
Provide regulatory support for IVD products with multiple product groups within clinical diagnostics. Work with regulatory database to post Instructions for use. Assembles low complexity regulatory submissions to support worldwide...
2 months ago seen See more...
- View all Quintalent Inc jobs - jobs in Hercules, CA
Software Regulatory Affairs Specialist
Nihon Kohden
Irvine, CA
Responsible for regulatory compliance, per Article 15 of the EU MDR. Prepare submissions for new products and product changes as required to ensure timely approval for market release. Review significant regulatory strategies with...
2 months ago seen See more...
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