Senior Regulatory Affairs Manager
- $100,000 - $100,000
- Johnson City, TX
A bit about us:
A global medical diagnostics business with specialisms in point-of-care testing, central laboratory tests, enzyme manufacturing and the provision of contract manufacturing services to the healthcare industry.
Why join us?
Medical insurance
Vision insurance
Dental insurance
401(k)
Disability insurance
Vision insurance
Dental insurance
401(k)
Disability insurance
Job Details
SUMMARY
Ensures that all products manufactured and services provided by the company meet the quality requirements of the company and adhere to regulatory requirements. Under the direction of the Global Head, QA & RA, responsible for maintaining the appropriate licensing of products for domestic markets and facilitate registration materials/documents to support our distributors in international markets.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Communicates with various government agencies to include, but not limited to, Food and Drug Administration (FDA), Texas Department of Health Human Services (TDHHS), Department of Public Safety (DPS), Environmental Protection Agency (EPA), Health Canada (HC), European Commission Health and Consumers (SANCO), and other international regulatory agencies.
Ensure compliance of EKF’s products in accordance with the relevant regulations.
To direct regulatory, registration and external affairs activities.
To monitor implementation of new regulatory / legal requirements (including environmental legislation) in the relevant countries.
Provides regulatory advice and strategies on development of new products or modifications of existing products following implemented procedures and policies.
Prepares and submits 510(k) notifications for the US market and other regulatory documents in support of specific country registrations requirements.
To provide regulatory support for EKF sales, marketing activities and serve as the regulatory interface with distributors.
Creates and/or reviews product information in relation to IFUs, labeling, sales and marketing literature.
Management of Technical Dossiers for CE marking of products for the European community.
Conducts training in cGMP, ISO regulations, and the implemented company’s Quality System.
Directs product vigilance/medical device adverse event reporting activities to include Medical Device Reporting (MDR) for the United States, and adverse reporting to Canadian and European authorities
Prepares and coordinates issuing of Technical Bulletins or Advisories.
Maintain regulatory establishment registration and listing with FDA.
Maintains regulatory licenses with Canada.
Directs activities of the quality system to ensure regulatory compliance to both national and international requirements.
Assists the QA Department as necessary.
SUPERVISORY RESPONSIBILITIES
Line management responsibility for RA Manager(s) and RA Associate(s).
EDUCATION and/or EXPERIENCE
Bachelor's degree (B.A./B.S.) from four-year college or university in a science related field
Minimum of five (5) years’ experience of working in regulated industry such as pharmaceuticals or medical devices.
Minimum of three (3) years’ In vitro Diagnostics (IVD) experience
Clinical Chemistry experience preferred
Ensures that all products manufactured and services provided by the company meet the quality requirements of the company and adhere to regulatory requirements. Under the direction of the Global Head, QA & RA, responsible for maintaining the appropriate licensing of products for domestic markets and facilitate registration materials/documents to support our distributors in international markets.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Communicates with various government agencies to include, but not limited to, Food and Drug Administration (FDA), Texas Department of Health Human Services (TDHHS), Department of Public Safety (DPS), Environmental Protection Agency (EPA), Health Canada (HC), European Commission Health and Consumers (SANCO), and other international regulatory agencies.
Ensure compliance of EKF’s products in accordance with the relevant regulations.
To direct regulatory, registration and external affairs activities.
To monitor implementation of new regulatory / legal requirements (including environmental legislation) in the relevant countries.
Provides regulatory advice and strategies on development of new products or modifications of existing products following implemented procedures and policies.
Prepares and submits 510(k) notifications for the US market and other regulatory documents in support of specific country registrations requirements.
To provide regulatory support for EKF sales, marketing activities and serve as the regulatory interface with distributors.
Creates and/or reviews product information in relation to IFUs, labeling, sales and marketing literature.
Management of Technical Dossiers for CE marking of products for the European community.
Conducts training in cGMP, ISO regulations, and the implemented company’s Quality System.
Directs product vigilance/medical device adverse event reporting activities to include Medical Device Reporting (MDR) for the United States, and adverse reporting to Canadian and European authorities
Prepares and coordinates issuing of Technical Bulletins or Advisories.
Maintain regulatory establishment registration and listing with FDA.
Maintains regulatory licenses with Canada.
Directs activities of the quality system to ensure regulatory compliance to both national and international requirements.
Assists the QA Department as necessary.
SUPERVISORY RESPONSIBILITIES
Line management responsibility for RA Manager(s) and RA Associate(s).
EDUCATION and/or EXPERIENCE
Bachelor's degree (B.A./B.S.) from four-year college or university in a science related field
Minimum of five (5) years’ experience of working in regulated industry such as pharmaceuticals or medical devices.
Minimum of three (3) years’ In vitro Diagnostics (IVD) experience
Clinical Chemistry experience preferred