- Medtronic (Minneapolis, MN)
- Position Description: Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing ... devices. Work on MDD (Medical Device Directive) design dossiers, MDR (Medical Device Regulation) technical files and change notifications...closely related field and 2 years' experience as a Regulatory Affairs Specialist , R&D Engineer… more
- Medtronic (Northridge, CA)
- …90,000+ employees in more than 160 countries. **A Day in the Life** As Principal Regulatory Affairs Specialist , you will develop and implement medical device ... agencies. + 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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …**True to Life.** **Job Description** The Specialist I - Regulatory Affairs will support the maintenance of EU MDR technical documentation and conduct ... other elements of sustaining Regulatory Affairs including maintaining "state of the...thinking and problem-solving skills. + Strong knowledge of EU MDR and other supporting regulatory requirements including… 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
- Stryker (Fremont, CA)
- …organization by visiting stryker.com We are currently seeking a **Senior Staff Regulatory Affairs Specialist ** to join our Neurovascular division ... improve. **What you will do** As the **Senior Staff Regulatory Affairs Specialist ** , you...of FDA and international medical device regulations/standards (eg EU MDR ) $127,400.00 - $210,100.00 USD salary plus bonus eligible… 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
- Healgen Scientific Limited (Houston, TX)
- Regulatory Affairs Specialist Regulatory ...as 21 CFR Part 820), ISO 13485, and other global regulatory requirements (such as MDR in the EU). ... and multiplex flow cytometry. About the role The purpose of a Regulatory Affairs Specialist is to ensure compliance with regulations and guidelines… 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
- 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
- Actalent (Littleton, MA)
- Description: The Regulatory Affairs Specialist is responsible for identifying, evaluating, and ensuring compliance with all applicable laws, regulations, and ... standards. The Regulatory Affairs Specialist shall also...verbal communication skills are essential. * Experience with EU MDR , ISO13485, FDA 510(k), PMA, IEC 60601, IEC 62304… 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
- Actalent (Cuyahoga Falls, OH)
- …Management System. SKILLS& QUALIFICATIONS REQUIRED + 3-5 years of progressive experience in regulatory affairs required + Prior knowledge of 21CFR 820, ISO13485, ... JOB DESCRIPTION + Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical... MDR QMS requirements required PREFERRED + Bachelor's degree in… 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
- Fresenius Medical Center (Ogden, UT)
- …Center/Project Manager to get part needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier/Registration dossier. + Provide ... relevant experience and/or education may be considered. + Minimum 2 years in Regulatory Affairs or similar in pharmaceutical/medical field + Strong relationship… more