Job DescriptionDr. Comfort is seeking a Senior Manager, Quality & Regulatory Affairs to serve as the single, accountable owner of product quality across our entire supply chain from domestically produced custom shoe inserts to finished footwear sourced from Asia Pacific manufacturing partners. This role unifies Quality Management, Regulatory Affairs, and Import/Trade Compliance under one accountabl...
Job DescriptionQuality Assurance & Regulatory Affairs | MedTech
I've partnered with a growing medical device business looking to strengthen its Regulatory Affairs and Quality Assurance function.
This is an opportunity to take ownership of regulatory compliance and quality processes, working closely with R&D, engineering and senior leadership to support product development and future commercial gr...
Job DescriptionAbout Slate
Slate Medicines is a clinical-stage biotechnology company committed to advancing innovative new therapies that may broaden the treatment paradigm and potentially improve outcomes for people with migraine and other headache disorders. Slate is advancing a portfolio of potentially best-in-class therapeutics, led by SLTE-1009, a clinical-stage anti-PACAP/VIP monoclonal antib...
Job DescriptionPosition Summary
Our Startup Client is seeking an experienced Vice President of Quality & Regulatory Affairs to lead the Quality and Regulatory functions for a clinical-stage biotechnology company developing innovative cell-based therapies.
This executive will have overall responsibility for establishing and maintaining a phase-appropriate Quality Management System, providingstrategi...
Job DescriptionCompany Description
Mazza Healthcare is a healthcare solutions company with strong expertise in global sourcing and private label portfolio development. We advance the cost-effectiveness and quality of healthcare products while remaining committed to patient safety. Mazza Healthcare has experienced rapid growth over the past several years and is currently seeking a Specialist, Qualit...
Job DescriptionMCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams com...
Job Description
About the Company
Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.
About the Role
The Regulatory Affairs Manager is responsible for supporting the development and e...
Job DescriptionPosition Overview
An established organization operating in a regulated product environment is seeking a Regulatory Affairs Specialist to support regulatory compliance, quality management systems, product registrations, and international market access.
This role will work cross-functionally with quality, engineering, product development, and other internal stakeholders to ensure prod...
Job DescriptionRegulatory 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 flagship platform is already used in thousands of procedures across the US, Europe, Canada and Australia, and they are g...
Job DescriptionDirector, Regulatory Affairs / Regulatory Services
Location: Remote – Applicants must be based in the Eastern or Central U.S. time zones.
Level: Director preferred; experienced Senior Managers will also be considered
Focus: US Regulatory Affairs / FDA
Reports to: Vice President, Regulatory Services
About the Role
We are seeking an experienced, hands-on Director of Regulatory Affai...
Job DescriptionSenior Director, Regulatory Affairs - Hybrid NYC Area
Key Responsibilities
Develop and execute regulatory strategies supporting clinical development and future product approvals.
Lead and support preparation and submission of regulatory filings, including INDs, NDAs, and international submissions.
Provide regulatory guidance to cross-functional teams throughout the product devel...
Sr. Regulatory Affairs SpecialistPosition SummaryThe Sr. Regulatory Affairs Specialist will be Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Ensuring that the company adheres to all relevant laws, regulations, and standards. The position requires good knowledge of industry regulations and effective communication skills ...
Job DescriptionChantecaille’s mission is to create luxurious botanical beauty with impact. For the past 25 years, the brand has been at the cutting-edge of some of the industry’s most exciting innovations in skincare and cosmetics, creating iconic products like Just Skin, Future Skin, Bio Lifting Serum+ and more that are beloved worldwide. Founded by beauty pioneer Sylvie Chantecaille in 1998, ...
Job DescriptionRegulatory Affairs Specialist, Oncology Clinical Research
*5-6 Month Contract*
Join a leading oncology clinical research organization known for connecting patients with cutting edge cancer treatments and advancing new therapies through clinical trials.
In this role, you will prepare and submit study documents to the IRB for assigned investigational drug studies, including protoc...
Our client, a global healthcare organization is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs team supporting division-level regulatory operations. The ideal candidate will have strong attention to detail, the ability to think critically about regulatory requirements, and the discipline to manage deadlines ...
Monitor and provide guidance on European Union medical device regulations as the subject matter expert, ensuring device certification process compliance, and coordinating with internal teams to address future developments.Education and Experience RequirementsBachelors degree in Pharmaceutical Sciences or related.Special Skills RequirementsTwo (2) years of experience evaluating European Union Regula...
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