Regulatory Affairs Specialist
Virtual Vocations Inc
Supporting global regulatory operations, the contract Regulatory Affairs Specialist in medical devices will compile technical documentation for submissions, collaborate with cross-functional teams, and assist in preparing responses to regulatory authorities, all while working remotely. Key responsibilities Compile, track, and organize technical documentation for global regulatory submissions Collaborate with cross-functional team members to gather scientific data and ensure project alignment Edit and proofread labeling, SOPs, and departmental technical documentation Required qualifications Bachelor's degree in a scientific discipline or equivalent field (non-scientific degrees accepted with relevant coursework/training) Strong problem-solving, project management, and multitasking abilities Excellent interpersonal and communication skills for cross-functional collaboration Proficiency in technical computer applications (spreadsheets, databases, word processing)
- The Compliance Specialist reports to the Director Legal, Compliance, Privacy & Security (“Director”) and has a key role in supporting the... ...basis.Conduct research and develop written communication on regulatory requirements to ensure ongoing updates upon request. Manage compliance...SuggestedContract work
- ...About the Role Our client is seeking a meticulous and proactive Regulatory Affairs Specialist to support their operations from Welkom . This role is essential for ensuring that all pharmaceutical products meet stringent regulatory requirements for approval and marketing...SuggestedRemote work
- ...Regulatory Affairs Specialist Regulatory Affairs Specialist manages assigned projects of moderate complexity which include international regulatory activities; on-market compliance reports or assessment of design changes, manufacturing process and labeling changes for...SuggestedFull timeWork at office
- ...Regulatory Affairs Specialist Location: Indianapolis, IN Duration: 18+ Months Description Qualifications: MUST REFLECT ON RESUME: 3+ years experience in a CMC/Chemistry Manufacturing and Controls position OR 3+ years Module 3 experience (regulatory app that...SuggestedWork at office
$90k - $140k
...Regulatory Strategy Lead For AI/ML-Based SaMD Product Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. Serve as regulatory lead for novel oncology diagnostic technologies integrating...Suggested$30 - $35 per hour
...Regulatory Affairs Specialist Volt is immediately hiring Regulatory Affairs Specialist in Topeka, KS. As a Regulatory Affairs Specialist, you will be responsible for preparing and submitting accurate regulatory documentation to USDA and other agencies. You will also...Hourly payFull timeContract workWork experience placementImmediate start- ...Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S... ...of international product registrations and related regulatory affairs activities, including execution of procedures and systems...Work at office
- ...Responsibilities: This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulations, ISO standards, and other...Work experience placementWork at office
$80k - $110k
...Regulatory Affairs Specialist The Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory initiatives and partnering with Sales and Marketing teams in obtaining domestic and internal regulatory...Work experience placementLocal areaWorldwideFlexible hours- ...Regulatory Affairs Specialist Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 199...
- ...Regulatory Affairs Specialist The Regulatory Affairs Specialist will assist in maintaining market authorizations for Scanlan products, including design files, technical documentation, product registrations and listings. They will also assist with post-market surveillance...Work experience placementWork at officeWorldwide
- ...Regulatory Affairs Specialist Assist Regulatory Personnel with the Completion of Work Packages for Development Projects: Draft Meeting Requests and Briefing Packages for FDA meetings, Investigational New Drug Applications, Supplemental Biologic License Applications...Remote work
- ...Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions... ...). minimum of 3 years' experience in Regulatory Affairs dvanced experience in the areas that may include preparation...Work at office
- ...Job Description Direct or performs coordination and preparation of document packages for regulatory submissions related to the Company separation from all areas of company, internal audits and inspections Lead and compile all materials required in submissions related...Extra incomeFull timeH1bLocal areaVisa sponsorshipWork visa
- ...Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software...
- ...Regulatory Affairs Specialist Peregrine Team is seeking a Regulatory Affairs Specialist to support global regulatory submissions and ensure compliance across pharmaceutical products. This role will work closely with cross-functional teams to support product approvals...
- ...Regulatory Affairs Specialist Are you looking for a company where your work has meaning, where you can make a real impact and learn every day? At Urgo Medical, we believe innovation can transform lives. Our mission: to help patients heal faster and better, through cutting...Local area
- ...and implements strategies and activities required to procure regulatory approval for new and revised product lines. Coordinates and prepares... ...accredited institution. Minimum of 3–5 years of regulatory affairs experience in the medical device industry. Solid knowledge...Temporary workMonday to FridayDay shift
- .... • Conduct evaluations of chemical formulations to support regulatory compliance determinations. • Administer regulatory label and... ...Policy: Skills and Requirements • 4+ years of Regulatory Affairs experience in a corporate environment • Bachelor's degree with...
$77.31k - $95.5k
...Regulatory Affairs Specialist Ensures that Roswell Park IND's/IDE's and other regulatory submission types are in compliance with FDA regulations; keeps current on changes in regulations for drugs, biologics, devices and tobacco products; advises investigators on FDA...Full time- ...markets worldwide. Support product registrations, including creating, revising, reviewing and compiling documents for submission to regulatory authorities, as well as assisting in responding to questions and requests from such authorities. Assist in external audits by...Worldwide
- ...Regulatory Affairs Specialist III Location: Bridgewater, NJ Duration: 9 Months Manager will consider candidates to be based in either Bridgewater, New Jersey or Cambridge, Massachusetts. Please specify on resume which location candidate is being submitted for....Worldwide
- ...Role Description This is a full-time on-site role for a Regulatory Affairs Specialist located in Torrance, CA. The Regulatory Affairs Specialist will be responsible for regulatory documentation, compliance, requirements, submissions, and overall regulatory affairs activities...Full time
- ...Regulatory Affairs Specialist This role is ideal for a regulatory professional with strong experience in FDA, Health Canada, and EU medical device requirements. The Regulatory Affairs Specialist will maintain global registrations and technical documentation, support...Work at office
$80k - $95k
...Regulatory Affairs Specialist The Regulatory Affairs Specialist is responsible for coordinating and executing routine regulatory activities that support the company's worldwide medical device business. This position supports product registrations, regulatory submissions...Work at officeWorldwideWeekend workAfternoon shift- ...Job Description - Regulatory Affairs Specialist Job Title: Regulatory Affairs Specialist Location: [City, State] / Remote / Hybrid Job Summary We are seeking a knowledgeable and detail-oriented Regulatory Affairs Specialist to support...Work at officeLocal areaRemote workFlexible hours
$35 - $45 per hour
...The Fountain Group is currently seeking a Regulatory Affairs Specialist for a prominent client of ours. This position is located in Trumbull,CT (Hybrid). Details for the position are as follows: ~ Pay: $35-45/hr. ~1 year assignment with possibility for extension...$75.1k
...We have a robust product portfolio and pipeline and continue to invest in urology treatments. This role is responsible for Regulatory Affairs support for submissions and ongoing regulatory compliance throughout the product development process. The role will also...Hourly payContract workWork at officeLocal areaRelocationRelocation packageShift work3 days per week- ...new software systems like SAP, AO Docs, or AI-assisted tools is a plus. Responsibilities: Prepare and submit accurate regulatory documentation to the USDA and other government agencies. Complete, verify, and track official Health Certificates required for...
- ...Job Responsibilities Determine international regulatory submission and approval requirements Compile, prepare, review regulatory submission with in-country representatives and ensure on-time submission to relevant authorities Anticipate regulatory obstacles and...Work experience placement
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist. Be the first to apply!
- hr compliance coordinator United States
- tax compliance analyst United States
- regulatory reporting analyst United States
- regulatory specialist United States
- junior compliance analyst United States
- compliance officer United States
- junior regulatory affairs specialist United States
- quality assurance compliance specialist United States
- coding compliance specialist United States
- entry level compliance analyst United States

