- DivIHN Integration Inc (Des Plaines, IL)
- …opportunity, please contact our Talent Specialists Meghna | 224 369 4230 Title: Regulatory Specialist I Location: Des Plaines, IL Duration: 8 Months Description: ... day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides… more
- STERIS (Eden Prairie, MN)
- Regulatory Affairs & Quality Compliance Specialist Req ID: 43211 Job Category: Regulatory Affairs Eden Prairie, MN, US, 55344 Description: At STERIS, ... the globe. Position Summary The mission of the STERIS Regulatory Affairs & Quality Compliance function is...position is a fully remote role. The Quality & Regulatory Compliance Specialist will develop a firm… more
- Medtronic (Santa Rosa, CA)
- Principal Regulatory Affairs Specialist - Structural Heart and Aortic, Mitral and Tricuspid (hybrid) Come be a part of one of the most exciting therapy areas ... Affairs team and looking to hire a Principal Regulatory Affairs Specialist to make...PMAs, IDE and PMA Supplements/Reports, Shonin applications, and EU MDR Technical Documentation in addition to Change Management assessments.… more
- Philips (San Diego, CA)
- …Implements internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will collaborate with ... and marketing strategy. **Your role:** + The Senior RA Specialist provides the regulatory plan, guidance on...for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems… more
- Medtronic (Plymouth, MN)
- REGULATORY AFFAIRS SPECIALIST - Peripheral Vascular Health (hybrid) Peripheral Vascular Health therapies are a critical part of the Medtronic vascular ... a global leader in medical technology and solutions. Careers that Change Lives: The Regulatory Affairs Specialist is responsible for worldwide regulatory … more
- Adecco US, Inc. (San Diego, CA)
- ** Regulatory Affairs Specialist ** Full Time San Diego, CA, US **Salary Range:** $90,000.00 To 110,000.00 Annually Monday - Friday, 8:30 am - 5:00 pm Who we ... that spans fixed, removable, ortho, implants, and equipment. About the Opportunity: The Regulatory Affairs Specialist is responsible for ensuring foreign and… more
- Actalent (Cuyahoga Falls, OH)
- …in accordance with cGMPs, QSRs, MDRs and the Quality Management System. Skills: Regulatory affairs , Regulatory , Medical device, Fda, Regulatory ... documents, Regulatory compliance, Iso 13485, Gmp, eu mdr , 21cfr 820, Labelling, Quality assurance, Compliance Additional Skills...is preferred. - 3-5 years of progressive experience in regulatory affairs required - Prior knowledge of… more
- Teleflex (Morrisville, NC)
- Regulatory Affairs Specialist **Date:** Apr 10, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... solutions that make a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies and submissions… more
- Kelly Services (Cuyahoga Falls, OH)
- Kelly Science & Clinical is seeking a **Senior Regulatory Affairs Specialist near Cuyahoga Falls, OH.** **Direct Hire** **Shift:** Monday - Friday 8am-5pm ... technology field + 5+ years of progressive experience in regulatory affairs required + Appropriate combination of...be acceptable + Prior knowledge of 21CFR 820, ISO13485, MDR QMS requirements required + Experience with medical device… more
- Kelly Services (Irvine, CA)
- ** Regulatory Affairs Specialist ** The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory ... with US and international regulatory requirements. The Regulatory Affairs Specialist provides direct...amended by 2007/47/EC) and CE marking is required; EU MDR familiarity is preferred. + Experience in the application… more
- Philips (Orange, OH)
- **Principal Regulatory Affairs Specialist (US Hub based)** Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of ... (CII) business unit._ + _Lead project teams for end-to-end Regulatory Affairs input and deliverables for new...of applicable regulations, standards and guidance for medical devices ( MDR , MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO… more
- ConvaTec (Lexington, MA)
- …Convatec, please visit http://www.convatecgroup.com **Job Summary:** In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be ... global regulatory strategies and processes. The Senior Regulatory Affairs Specialist will drive...820 and EU Medical Devices Directive 93/42/EEC / EU MDR 2017/745: + 510(k) submissions, 3-5 minimum + Preparation… more
- Philips (Colorado Springs, CO)
- The Principal Regulatory Affairs Specialist will play a critical role in ensuring our Coronary Vascular products are safe, reliable, and compliant with ... Affairs experience within FDA regulated medical device/technology environments, including- regulatory approvals, submittals-FDA 510K, PMA, IDE, EU MDD/ MDR ,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Regulatory Affairs Specialist , Infusion, you will be responsible for Regulatory Affairs projects within the ... Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution...to align with new regulations and requirements, ie, EU MDR , MDSAP. + Review changes and related documentation to… more
- Abbott (Atlanta, GA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Heart Failure ... Division. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible...QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR ),… more
- Philips (Nashville, TN)
- **Principal Regulatory Affairs Specialist - Software & Artificial Intelligence (US Hub Based)** The Principal Regulatory Affairs Specialist - SW & ... AI will shape, lead and execute innovative regulatory strategies to drive innovation within the Philips Innovation...Experience with US FDA De Novo, CE marking under MDD/ MDR and international registration in emerging markets such as… more
- Envista Holdings Corporation (Brea, CA)
- **Job Description:** The ** Regulatory Affairs Specialist ** will be responsible for establishing, coordinating, and executing user experience / design ... with strong focus on the new Medical Device Regulation ( MDR ) and FDA IRB studies. He or she coordinates...that are complaint to the new Medical Device Regulation ( MDR ) and/or FDA IRB studies within a product development… more
- Bausch Health (Bothell, WA)
- …a science related field. + Should have over 7 years of experience as Sr. Regulatory Affairs Specialist . + Should have experience of independently authoring ... care options to consumers and physicians alike. The Manager, Regulatory Affairs provides direct support to Solta...Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above). +… more
- Stryker (Mahwah, NJ)
- …Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory ... information is available at www.stryker.com We are currently seeking a **Senior Specialist , Regulatory Compliance** to join our Joint Replacement Division based… more
- Stryker (Mahwah, NJ)
- …Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory ... organization by visiting stryker.com We are currently seeking a **Senior Staff Specialist , Regulatory Compliance** to join our **Joint Replacement Division**… more
