Regulatory Affairs Specialist

Regulatory Affairs Specialist (Hybrid)ID 2024-1758Category Product StewardshipPosition Type SalariedRemote NoShift Time 40OverviewAt Benjamin Moore, we empower our team members to achieve their goals and make a positive impact in our communities. We offer a rewarding and inspiring work environment that fosters creativity, collaboration, and a strong...

Top 3-5 skills, experience or education required1. Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.3. Detail-oriented with the ability to proofread and check documents for accuracy and consistency.Purpose Statement:The Regulatory Affairs Specialist supports the development...

Regulatory Affairs CoordinatorCity: FriscoState: TexasZip: 75034CornerStone Professional Placement has partnered with a reputable medical device manufacturing client seeking a Regulatory Affairs Coordinator. As the Regulatory Affairs Coordinator, you will be responsible for assisting the Regulatory Affairs team with gathering and organizing documents for...

Overview of the Role:The Senior Regulatory Specialist provides comprehensive regulatory expertise, supporting daily departmental operations and collaborating with the Manager of Regulatory Affairs to manage global medical device registrations. This role involves ensuring the department’s compliance with regulatory policies and managing both electronic and...

Regulatory Affairs Specialist II Location: Irvine, CA (Hybrid 3 days on site)12 month AssignmentPay Rate: $45-$49/hr.On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE...

Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...

At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

We are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This On-site role reports directly to the CEO. The Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory...

Director, Regulatory Affairs CMC Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...

Director, Regulatory Affairs CMC - Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...

Job Title: Director Regulatory AffairsLocation: Weston, FL (near Miami and Fort Lauderdale, Florida (FL))Function: Regulatory AffairsReports to: Chief Regulatory Affairs Officer Job Summary:The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre-...

Regulatory Affairs AssociateLocation: Fremont, CAOur innovative client is seeking a Regulatory Affairs Associate to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and...

Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD). Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the...

Senior Regulatory Affairs Associate must understand the organization's consulting models and methodologies, as well having as good knowledge of what services PC provides. The Senior Regulatory Affairs Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization...

Position Summary: We are seeking a highly skilled and detail-oriented Manager of Regulatory Affairs and Compliance to lead and oversee the organization's regulatory activities. This position plays a critical role in ensuring that the company complies with all applicable laws, regulations, and industry standards, while also managing the development and...

Role: Senior Regulatory Affairs Lead, Location: Orlando, FLAdvise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending country guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives and project strategy.Create detailed written regulatory plans that can be...

Our partner specializes in their patented resources and ingredients, servicing the community with their profound discoveries globally in the biopharma space. They are in search of a Regulatory Affairs Specialist to play an exciting role across their innovative processes in LA!Schedule: Mon-Fri -8am-5pm (Hybrid)Salary: $85k - $100kDirect Hire...

Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

Invenia is working with a growing manufacturer of scientific instrumentation to hire a Director of Regulatory Affairs.The company manufactures cell biology tools to advance workflows in the cell & gene therapy and bioproduction markets. They have an has an excellent culture and truly value their employees.The role:The Director of Regulatory Affairs will be...