Tuesday, September 4, 2018

Regulatory Consultant, Medical Device MDSS - Carlsbad, CA.


Individual must plan, implant and ensure compliance of the Technical File to the medical device regulation. Must have expertise of registering products with one of the EU authorized representatives. Expert in Technical Files. Minimum 5 years expereince.
https://www.indeed.com/viewjob?t=regulatory+consultant+medical+device+mdss&jk=78645894c381171b&_ga=2.58306858.1217839535.1536065202-2077807285.1533320279

Regulatory Specialist, Medical Device Registrations - Carlsbad, CA.


Individual must plan, implant and ensure compliance to global registration in terms of change in the legal manufacturer. Ensure proper time invested to re-register products globally. Expert in global registration.
https://www.indeed.com/viewjob?t=regulatory+specialist+medical+device+registrations&jk=1c560c04d81e96e9&_ga=2.58306858.1217839535.1536065202-2077807285.1533320279

Regulatory Specialist, Medical Devices ISO & MDSAP - Carlsbad, CA.


Individual must ensure that the requirements for ISO 13485:2016 / Medical Device Single Audit Program (MDSAP) are incorporated into the Quality Management Systems (QMS). Individual must plan, implant and ensure compliance to Medical Device Single Audit Program (MDSAP).
https://www.indeed.com/viewjob?t=regulatory+specialist+medical+devices+iso+mdsap&jk=878234731cd3b6bf&_ga=2.58306858.1217839535.1536065202-2077807285.1533320279

Medical Writer, Clinical Research - Lexington, MA.


Medical Writer (MW) is responsible for medical writing activities related to clinical documents (eg, investigators brochures, study protocol and amendments, study reports, marketing authorization submission documents).
https://www.indeed.com/viewjob?t=medical+writer+clinical+research&jk=0c379025f5041591&_ga=2.54197544.1217839535.1536065202-2077807285.1533320279

Post Market Surveillance Specialist, Medical Devices - Carlsbad, CA.


Individual must ensure that the requirements for post market surveillance reports are met through creating reports and obtaining data such as Risk Assessments, Clinical Evaluation Reports, Complaints, Vigilance, Medical Device Reports, CAPAs etc. by working with the cross functional teams.
https://www.indeed.com/viewjob?t=post+market+surveillance+specialist+medical+devices&jk=1821c0dbad9f8b90&_ga=2.58306858.1217839535.1536065202-2077807285.1533320279

Senior Regulatory Affairs Consultant, Medical Devices - Carlsbad, CA.


Individual must plan, implant and ensure compliance to EU MDR. Lead cross-functional teams. Coordinate activities/tasks and resources across affected departments. Identify gaps and resolves issues related to EU MDR. Expert in EU MDR. Minimum 10 years expereince.
https://www.indeed.com/viewjob?t=senior+regulatory+affairs+consultant+medical+devices&jk=46351922cf239142&_ga=2.92010522.1217839535.1536065202-2077807285.1533320279

Saturday, September 1, 2018

Argus Technical Consultant - Irvine, CA - www.KatalystHLS.com


Argus Technical Consultant role engages with IT and business for the Argus migration activities. Conduct user requirement gathering for Argus migration and transform user requirements to functional requirements leading into migration and system design. Develop business process workflow diagrams and system level logical/physical architecture diagrams.
https://www.indeed.com/viewjob?t=argus+technical+consultant&jk=0c6115ecf1f3e705&_ga=2.139292275.1982000693.1535723830-2077807285.1533320279