- University of Pennsylvania (Philadelphia, PA)
- …needed and/or planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA, ... planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA, via electronic… more
- Teleflex (Maple Grove, MN)
- …a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies, submissions , and regulatory reviews of ... Regulatory Affairs Specialist **Date:** Sep 14,...product development to assure collection of appropriate data for regulatory submissions and regulatory compliance.… more
- University of Pennsylvania (Philadelphia, PA)
- …such as: Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions . Communicate with study team members. ... submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects occur throughout the… more
- Regeneron Pharmaceuticals (Troy, NY)
- …global markets. + Lead the preparation, coordination, and compilation of CMC regulatory submissions for non-US/EU markets in accordance with local regulations ... Regeneron is currently looking for a Staff CMC Regulatory Sciences Specialist for our CMC...health agencies in support of the CMC modules of regulatory submissions . + Keeps all stakeholders, including… more
- LSI Solutions (Victor, NY)
- …state-of-the-art devices. After all, our customer is ultimately the patient. JOB TITLE: Regulatory Specialist (Labeling) - Days 8:00AM to 5:00PM SALARY RANGE: ... at LSI Solutions in Victor, NY JOB SUMMARY: The Regulatory Specialist applies her/his experience, knowledge, organization...to Domestic Regulatory Projects will 1) prepare regulatory submissions , including FDA Q- Submissions ,… more
- Globus Medical, Inc. (Audubon, PA)
- …medical device development and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains...Specialist drafts, submits and gains clearance for 510(k) submissions , and approval for IDE/PMA submissions to… more
- Kelly Services (Redondo Beach, CA)
- …Operations to Ensure Clinical Study Results and Reports are Suitable for Regulatory Submissions + Responsible for Adverse Event (Vigilance, MDR) Reporting ... **Title** : Regulatory Affairs Specialist (Senior Level) **Pay**...Regulatory Representative to Marketing, Clinical, Research Teams, and Regulatory Agencies + Ensure Regulatory Submissions… more
- Caldera Medical (Westlake Village, CA)
- Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for Women! As a ... regulatory specialist , you will develop and implement...worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on… more
- Randstad US (Fort Worth, TX)
- …post-inspection follow-up information as requested. + Coordinate, prepare, or review regulatory submissions for domestic or international projects. + Interpret ... regulatory affairs specialist i. + fort...of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy,… more
- University of Pennsylvania (Philadelphia, PA)
- …affairs as assigned. Job Description + Clinical Research Regulatory Affairs Specialist A Assist in Clinical Trial proposal submissions . Provides day-to-day ... resources, and much more. Posted Job Title Clinical Research Regulatory Specialist A (Department of Otorhinolaryngology) Job... regulatory contact for a study, handling all regulatory submissions , regulatory binders, monitor… more
- Medtronic (Minneapolis, MN)
- …Regulatory Affairs Manager. **Role and Responsibilities** + Prepare or assist in global regulatory submissions such as original IDE, original PMA and 510(k) ... can get back to enjoying what they love. The ** Regulatory Affairs Specialist ** will provide worldwide ...510(k)/IDE/PMA device/combination product submissions and other worldwide submissions and clearances + Experience with regulatory … more
- Randstad US (Los Angeles, CA)
- regulatory specialist . + los angeles , california (remote) + posted 5 days ago **job details** summary + $40 per hour + contract + bachelor degree + category ... + Utilize scientific training to guide experimentation scope and data selection for regulatory submissions . + Interact with regulatory authorities on… more
- Medtronic (Minneapolis, MN)
- … affairs specialist and in country specialists as needed, to support regulatory submissions worldwide for Class I, II, and Class III medical devices. ... II and Class III medical devices. The Sr Principal Regulatory Affairs Specialist is responsible for activities...Activities will include careful and clear documentation of regulatory decisions, authoring well written submissions to… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** Senior Regulatory Affairs Specialist - hybrid - Covington, Georgia Urology and Critical Care (UCC) is an established and trusted ... process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation...Author and support 510(k), Tech File / STED File submissions as required. + Provide regulatory support… more
- AON (SC)
- … regulatory filings for multiple clients. + Monitor deadlines for all regulatory submissions and ensure timely and accurate reporting. + Stay informed ... Aon is currently recruiting for a Regulatory Compliance Specialist - open to...filings for multiple clients. + Monitor deadlines for all regulatory submissions and ensure timely and accurate… more
- Medtronic (Minneapolis, MN)
- …devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with ... and Manufacturing site registrations. **Role and Responsibilities:** + Author and prepare regulatory submissions for new products and their product changes as… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …the regulatory submission or complete submission. + Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the ... Ability to comprehend technical documents and concepts. **External-Facing Title:** Senior Specialist Regulatory Affairs **Posting Country:** US - United States… more
- Abbott (Alameda, CA)
- …life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or ... regulations or with EU and other international medical device regulations and submissions . + Familiar with relevant regulatory requirements for medical devices,… more
- Medtronic (San Antonio, TX)
- …with the international regulatory affairs group to support regulatory submissions worldwide for electrosurgical devices (eg, electrosurgical generators, ... compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist will play a key...or performs coordination and preparation of document packages for regulatory submissions from all areas of company,… more
- Medtronic (Irvine, CA)
- …partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing ... a global medical technology and solutions leader. The **Senior Regulatory Affairs Specialist ** will be vital in...PMA Supplement, and technical documents to support CE mark/MDR submissions . + Manage multiple projects and prioritize tasks to… more
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