Regulatory Affairs Specialist
Virtual Vocations Inc
To support global regulatory compliance, the full-time Regulatory Affairs Specialist will manage documentation, assist with product registration and claims substantiation, and stay updated on international regulations while working remotely. Key responsibilities Support the development and execution of regulatory strategy for product compliance across US and international markets Collect, review, and maintain regulatory documentation and Product Information Files (PIFs) Assist with ongoing regulation monitoring and provide guidance on regulatory requirements throughout the product lifecycle Required qualifications Bachelor's degree in Chemistry, Biological Sciences, Biochemistry, Cosmetic Science Regulatory Affairs, or a related field 2+ years of experience in regulatory affairs, preferably in the cosmetics or consumer products industry Hands-on experience with global regulatory compliance documentation, including MoCRA and EU regulations Strong documentation skills and experience managing multiple projects simultaneously Technical curiosity and a collaborative, resourceful mindset
- ...Regulatory Affairs Specialist Job Type: Full time - Permanent Location: Madison, New Jersey (On-site) A commercial-stage transplant technology company, part of a global medtech group, is changing how donor organs are preserved and assessed before transplant. Their...SuggestedPermanent employmentFull time
$38 - $56 per hour
...LHH Recruitment Solutions is seeking a Regulatory Affairs Specialist for a minimum 6-month remote contract opportunity. This position is open to candidates residing in California who have prior experience in the medical device industry. The ideal candidate will have a...SuggestedHourly payContract workLocal areaImmediate startRemote workMonday to Friday- ...QMS Consulting seeks a Regulatory Specialist with direct experience drafting federal rules for the a federal agriculture agency. The specialist will serve as a rulemaking subject matter lead for up to three proposed-rule efforts. Working with QMS analysts and federal...SuggestedPermanent employmentFull time
$77k - $128.3k
...communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.Position Summary The Regulatory Affairs Manager (P3), Complex Molecules & Specialized Distribution Programs, supports regulatory compliance for pharmaceutical...SuggestedFull timeWork at office- The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance...Suggested
- ...both internal and external cross-functional project teams.• The Regulatory CMC Technical Associate may be called upon to author technical... ...Master s Degree a plus• 4+ years of pharmaceutical regulatory affairs experience• Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or...Work at officeLocal areaImmediate start
- ...financial flexibility by offering contingent labor as a variable cost.Job DescriptionThis individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual...Work at officeImmediate start
- ...is working in the CMC area. Relevant experience is requiredExperience: 3 to 6 yearsExperience with drug/biologics licensurePrior regulatory experienceTechnical writing experience (CMC experience )Scientific background,Required Skills:CMC/ Regulatory writing experienceScientific...Work at officeImmediate start
$107.2k - $160.8k
...font-size: 30px; font-weight: bold; width: 883px; left: 5px; height: 72px; padding-left: 17px; padding-top: 15px; } he Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast’s quality system and...Work at officeLocal areaImmediate startFlexible hours- Job-ID31525652Reference25-04486 Responsibilities: The Regulatory Affairs Specialist is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality...
- 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 as a medical device, and...
- Job-ID32758545Reference26-01317Remote50% Remote Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This...Remote work
- ...provides flexibility to work 4 days on site and Friday remotely on a weekly basis in Covington, GA. *** Job DescriptionThe Regulatory Affairs Specialist II is responsible for implementation of regulatory strategies including domestic and international submissions and other...Full timeWork at officeRemote workDay shift
- ...healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other...Full timeWork at officeRemote workDay shift
- 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...Contract work
- ...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
- ...solutions. 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
- Brecksville, OHDescriptionJob Title: Regulatory Affairs SpecialistDepartment: RegulatoryReports To: Director of Regulatory AffairsFLSA Status: ExemptSupervise the work of others: NoPosition Summary:This position is responsible for preparing submissions to various regulatory...Work experience placementWork at office
$90k - $125k
Alameda, CAGeneral Administration - Regulatory Affairs /External /HybridIn this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide...Temporary workWork at officeLocal areaWorldwide- ...439Reference25-02134 Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic... ...equivalent). A minimum of 3 years' experience in Regulatory Affairs Advanced experience in the areas that may include preparation...Work at office
- ...execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the...Immediate start
- ...medical technology or similar. 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the... ...verbal and written communication skills. Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.
- Job-ID31824874Reference26-00210 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...
$85k - $110k
...In this role you will collaborate with Regulatory Team in interpreting global regulations,... ...groups (ACA). A SUCCESSFUL REGULATORY SPECIALIST HAS THE FOLLOWING: Strong knowledge of... ...~3+ years of experience in Regulatory Affairs, Product Safety, Product Compliance, or...Work at office- ...wij op zoek naar een nauwkeurige en proactieve collega voor ons Regulatory team. Jouw rol Jij ondersteunt de afdeling bij het... ...updates van bestaande wetgeving in samenspraak met de Regulatory affairs manager. Jouw profiel Je bent in het bezit van een bachelor...Flexible hours
$55 - $60 per hour
...Take your regulatory affairs expertise to the next level with an opportunity to support innovative diagnostic products on a global scale.... ...5:00 PM Why This Role Matters As a Regulatory Affairs Specialist III, you will help ensure critical diagnostic products meet...Hourly payTemporary workMonday to Friday- ...Regulatory Affairs SpecialistIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission...
$28 - $30 per hour
...Regulatory Affairs SpecialistTitle - Regulatory Affairs Specialist Location - Remote Pay Rate - $28-30/HR OPEN to remote candidatesAssist Regulatory Personnel with the Completion of Work Packages for Development Projects:Draft Meeting Requests and Briefing Packages for...Remote work$80k - $100k
...making an impact in the lives of others. Learn about the Danaher Business System which makes everything possible. The Regulatory Affairs Specialist is responsible for obtaining domestic and internal regulatory clearances for Masimo products to meet business...Work experience placementWorldwide- ...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...
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