European Union Regulatory Affairs, Medical Device, Quality/Risk Management
Novosanis is a wholly owned subsidiary of OraSure Technologies Inc (NASDAQ: OSUR) and an innovative developer and producer of medical devices improving the quality of diagnostic tests as well as the accuracy of drug delivery for infectious diseases and oncology. We are looking for a Regulatory Affairs Specialist to strengthen our Design & Engineering team. Additional information on Novosanis and its devices on: www.novosanis.com/devices
Obtaining registration approvals from national authorities globally.
Monitoring current valid registrations for deadlines and expiry dates.
Working with QMS to keep technical documentation and registration files current with latest ISO standards.
Regulatory compliance of materials and labeling before batch release.
Notifying the necessary authorities with respect to CE marked products and partnering with them on vigilance issues.
following up on post-market surveillance obligations.
Gathering all relevant regulatory information from registrations and creating an up-to-date database accessible by all team members.
Responsible for regulatory strategy for Novosanis' Medical Devices & IVD.
Submitting applications for CE marking for IVD and Medical Device products and following-up on registrations (IvDD/MDD & IVDR/MDR).
US:FDA listing- approvals as appropriate.
Submitting renewals & reviewing technical documentation for registration, renewal and variations.
Responding to inquiries for regulatory body's to obtain approvals.
Prioritizing the list of new submission files & renewals in a registration priority list.
Managing the transition of directives to regulations.
Gathering country-specific intel and preparing product/country strategy for US/CA, AU/NZ, ASEAN, APEC, EMEA, Saudi-Arabia, South Africa, Iran, Non-EU.
Keeping up to date with current regulations for submitting new files, renewals and variations in all markets.
Quality Management System.
Support QMS by owning regulatory compliance, label design and development and post-market surveillance processes including recalls and regulatory notifications.
Medical device reporting.
Performing GAP analysis, audit preparations and ISO implementations and keeping current with ISO standards.
Providing guidance on implementatuin of MDSAP, FDA.
Preparing technical files and reviewing in QMS for MD and IVD
Providing regulatory input in design and clinical trials
Managing compliance with changing laws, guidelines and regulations
Supporting product changes, label changes, label verifications, IFU translations, version-controlled artwork, UDI research by providing regulatory expertise and risk assessment.
Providing guidance on necessary testing for registration of Novosanis' Medical Devices & IVD.
Transportations & logistics.
Assessing WHO- ICH stability requirements for reagents in zone III and IV climate zones.
Transportation of infectious samples (IATA & UN regulations)
Assisting in customs clearance for shipments and reviewing shipping documents & label requirements for globally-shipped products
Applying for Free Sale Certificates & coordinating the legalization of official documents needed for submissions
Marketing & Communications.
Coordinating brand name registration, company name registration and logo registrations
Reviewing and approving customer-facing marketing materials including spec sheets, commercial brochures, webpages, social media posts to ensure they comply with currently approved claims.
Providing regulatory support & guidance to the DNA Genotek business unit.
Acting as European Representative for US & Canada product sold into Europe.
Maintaining good contacts with regulatory agents, distributors, notified bodies and competent authorities.
Other duties as appropriate for a Regulatory Affairs Specialist
Master’s degree in Biomedical Engineering or Biomedical/Pharmaceutical Sciences
Minimum 2 years of experience in Regulatory Affairs role with In-Vitro Diagnostics manufacturer
Strong knowledge of international IVD and MD Classification and Regulations
Willing/able to travel as necessary
Good computer skills
Good communication skills
Excellent knowledge of English, Dutch and/or French (reading, writing & conversational)
Expertise in the following areas:
Regulatory Strategy & Mapping
What do we offer?
The opportunity to be part of a fast-growing & innovative company
Be part of a young and dynamic team
Competitive salary and fringe benefits
Additional Salary Information: Based on experience
Internal Number: 1
OraSure Technologies is empowering the global community to improve health and wellness by providing access to accurate essential information. OraSure is a leader in the development, manufacture and distribution of point-of-care diagnostic tests, molecular collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the OraQuick® platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse. Together with its wholly-owned subsidiaries (DNA Genotek, CoreBiome and Novosanis), OraSure provides its customers with value-added, end-to-end solutions that encompass tools, diagnostics and services.
OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research institutions, distributors, government agencies, physicians' offices, commercial and industrial entities, as well as direct to consumers.