- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... by law.Arthrex, Inc. is a world leader in orthopedic medical device innovation and education, dedicated to...We are currently seeking a motivated International Regulatory Affairs Specialist I to join our collaborative team at our… more
- DivIHN Integration Inc (Lake Forest, IL)
- …for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product ... our Talent Specialists Rashi at ### Title: Regulatory Affairs Specialist II - 5 Openings Location: Lake Forest, IL...compliance to the appropriate quality system for the specific medical device (s) designed or manufactured that the… more
- DivIHN Integration Inc (Scarborough, ME)
- …and ensures compliance to the appropriate quality system for the specific medical device (s) designed or manufactured that the individual supports. Ensures ... the following opportunity, please contact one of our Talent Specialist Rashi | 630 8471027 Title: Regulatory Specialist...writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support… more
- DivIHN Integration Inc (Lake Forest, IL)
- …for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product ... is required. PREFERRED QUALIFICATIONS: 1 years' experience in an IVD or medical device manufacturing environment. COMPETENCIES: Good knowledge of EU and… more
- DivIHN Integration Inc (Santa Clara, CA)
- …and ensures compliance to the appropriate quality system for the specific medical device (s) designed or manufactured that the individual supports. Ensures ... Specialists Rashi at ### Divya at ### Title: Regulatory Specialist II Location: Santa Clara, CA Duration: 6 Months...of EU and US) product registrations; experience working with medical device operations on control of product… more
- DivIHN Integration Inc (Alameda, CA)
- …to do the tasks. Regardless of education, looking for 5 years of experience Medical device experience required. Internship experience not acceptable. Needs to be ... Talent Specialists Divya at 224 369 2969 Title: RA Specialist II Location: Alameda, CA Duration: 12 Months Job...Strict to work 40hrs per week. Experience Background (Any): Medical Device , Pharmaceutical, Regulatory Affairs, Quality Assurance,… more
- Zimmer Biomet (Warsaw, IN)
- …and recognized. **What You Can Expect** This office position is responsible for leading medical device labeling projects (including, but not limited to ... product labels, IFUs, translations, labeling systems, and UDI initiatives) as necessary to market...and MDD/MDR regulations preferred. Ability to stay abreast of medical device regulations. + Demonstration of strong… more
- Medtronic (Santa Ana, CA)
- …our team! **A Day in the Life** * Create, review, and reproduce text required for labeling medical products * Ensure that labeling , art, film, and plate ... and using new computer systems and program * Experience working in the medical device or pharmaceutical industry **About Medtronic** Together, we can change… more
- Edwards Lifesciences (Irvine, CA)
- **Job Description:** The Sr. Labeling Specialist , Localization will partner with vendors and internal stakeholders on translation projects to ensure timely ... PO's and management of other localization related documents and procedures. The Sr. Labeling Specialist , Localization will support new product launches and base… more
- J&J Family of Companies (Raynham, MA)
- Regulatory Affairs Specialist I (Depuy Synthes/Spine) - Medical Device Business Services, Inc. (1 of 2) - 2406183699W **Description** DePuy Synthes, part of ... years' of regulatory experience in a highly regulated industry, preferably in medical device or pharmaceutical. _Relevant internship experience may be… more
- ICU Medical (Lake Forest, IL)
- …US state or territory in good standing . Minimum 7 years experience in medical device industry . Minimum 5 years of clinical experience *Minimum Qualifications* ... discriminated against on the basis of disability. **Title:** *Senior Clinical Specialist , Medical Affairs (Hybrid)* **Location:** *IL-Lake Forest* **Requisition… more
- Healgen Scientific Limited (Houston, TX)
- …Healgen and private brand labeling . Create and submit applications for medical device registration, private label requests, and licenses to regulatory ... Regulatory Affairs Specialist Regulatory Affairs | Houston, TX Apply Now...sold. Responsibilities Ensure timely and accurate regulatory submissions of medical device incident reporting. Review and approve… more
- Medtronic (Mounds View, MN)
- …lab. + Ability to perform patient assessments. + 3+ years experience in the medical device industry preferred. + Basic ability to understand and apply practical ... come together- everyone wins. We are seeking a Senior Medical Safety Specialist who will be primarily...proficient knowledge of assigned products and therapies, such as device design and function, product labeling , indications,… more
- Hologic (Newark, DE)
- …Degree, 0-2 Years with Master's Degree + Experience working in regulated medical device industry. **Skills** + Strong communication, including written, verbal, ... well as internal audits and inspections. We expect the **Regulatory Affairs Specialist ** to make recommendation changes for labeling , manufacturing, marketing… more
- Medtronic (Northridge, CA)
- …As Principal Regulatory Affairs Specialist , you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... professional to take their career to the next level at the world's leading medical device company. Responsibilities may include the following and other duties… more
- Medtronic (Plymouth, MN)
- …regulatory professional to take their career to the next level at the world's leading medical device company. This role will be based in either Minneapolis, MN ... Senior Regulatory Affairs Specialist - Peripheral Vascular Health (hybrid) Together, we...profile. + Bachelor's Degree + Minimum 4 years of medical device experience, with work experience in… more
- Integra LifeSciences (GA)
- …teams, quality teams). + Strong working knowledge of domestic and/or international medical device regulations including 510k, PMA, PMA Supplements,361 HCT/Ps, ... with corporate and international regulatory teams. + Lead Unique Device Identification system requirements and other labeling ...and international dossier submissions; Experience with medical device , biologic or implantable products is… more
- Stryker (Fremont, CA)
- …+ Understands: biocompatibility requirements, CMDRs, Design Control, Medical Device Directive, Essential Requirements, ISO 13485 , labeling requirements, ... We are currently seeking a **Senior Staff Regulatory Affairs Specialist ** to join our Neurovascular division based hybrid in...FDA regulated environment required + 5+ years' experience in medical device regulatory affairs required + RAC… more
- Medtronic (Miami Lakes, FL)
- …technical discipline + Minimum 4 years of experience in regulatory affairs in the medical device industry with Bachelor's degree + Minimum 2 years of experience ... Senior Regulatory Affairs Specialist - Mechanical Circulatory Support (hybrid) Join a...in regulatory affairs, in the medical device industry with Master's degree Nice… more
- Medtronic (Minneapolis, MN)
- …submissions for US Class III or Class II medical devices. Work on MDD ( Medical Device Directive) design dossiers, MDR ( Medical Device Regulation) ... Position Description: Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions...to Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive (EU MDD 93/42/EEC), Canadian… more
