What are the responsibilities and job description for the Dir of QMS Compliance/Regulatory Affairs position at Vivalnk Inc?
Job Description
Job Description
Qualifications :
10 years related experience in a fast-paced medical device, including start-up environment.
Bachelor’s Degree in a scientific discipline
Ability to review technical / regulatory documents and provide applicable inputs
Hands-on Experience of 510K and CE submissions for US FDA CE regulations, including SaMD.
Hands on Experience with regulatory compliance for 21CFR 820, ISO 13485 : 2016, EU Medical Device Regulation (EU MDR), and other applicable Standards for Class II medical device.
Able to provide thorough, practicable, creative but compliant solutions, consistent with
organization objectives, to a wide range of regulatory challenges.
Have been the company’s management representative to FDA and CE / notified body.
Experience with clinical data collection, if applicable, on medical device.
Experience with Post market surveillance (PMS), Post maker clinical follow Up (PMCF), GSPR and CER update for CE / MDR.
Experience with letter to file (LTF) and assessment if submission is needed for FDA CE .
Experience with FDA facility registration and device listing.
Experience with international product registration (i.e., Canada, Latin America, Europe, Japan, Asia, and …. per request) .
Experience with QMS documents / compliance following ISO 13485 : 2016
Proficiency in Words, Excel, Power Point
Attention to detail and organization skills
Demonstrate excellent people skills
RAC certificate
Responsibilities :
Provide regulatory support to customers about company products / services.
Lead the regulatory submission of Class II device for 510K / FDA and CE / MDR (may include SaMD and working with contractors and collecting clinical data if needed).
Be the company’s regulatory representative.
Host audits from customers and from notified body / regulatory agencies FDA
Lead international regulatory registration (i.e., Canada, Latin America, Europe, Japan, Asia, and ….) per request.
Enforce QMS documents / compliance per ISO 13485.
Provide input / comment about Regulatory status of medical device and services.
Responsible for PMS PMCF Tech File GSPR CER for CE and Letter to file for FDA as needed.
Maintain current ISO 13485 CE certifications FDA registrations.
Working with other teams on official releases and doc control.
Notice to customers on applicable releases / changes.
Company Description
Vivalink
Campbell, CA
Company
Silicon Valley-based Vivalink (www.vivalnk.com) is an innovative connected healthcare devices company in its growth stage. The company develops wearable telemetry devices with integrated biometric sensors designed to continuously monitor human vitals and other indicators for medical and healthcare applications. These devices together with Vivalink’s related healthcare software products and services are offered to enterprise customers under a platform as a service model. Over 300 leading organizations, in more than 50 countries depend on our wearable human vitalssensors, software and services. With great products, more than 20 patents and brilliant people, what we do matters.
Company Description
Vivalink Campbell, CA Company Silicon Valley-based Vivalink (www.vivalnk.com) is an innovative connected healthcare devices company in its growth stage. The company develops wearable telemetry devices with integrated biometric sensors designed to continuously monitor human vitals and other indicators for medical and healthcare applications. These devices together with Vivalink’s related healthcare software products and services are offered to enterprise customers under a platform as a service model. Over 300 leading organizations, in more than 50 countries depend on our wearable human vitalssensors, software and services. With great products, more than 20 patents and brilliant people, what we do matters.