Quidel Corporation is a is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia, Solana, Lyra, Triage and QuickVue, Quidel's comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel's mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world.
SUMMARY OF POSITION -
The Regulatory Affairs Specialist implements regulatory activities related to the approval of new IVDs (in vitro diagnostics and medical devices) into the worldwide market, as directed.
ESSENTIAL FUNCTIONS -
O Prepares regulatory documentation for domestic (FDA) and international (e.g., Canada, EU, etc.) product submissions and registrations; and secures regulatory documentation including device licenses, device listings, permits and import/export certificates.
O Supports corporate regulatory compliance activities including
* Comprehensive Compliance Program (CCP),
* provides regulatory guidance, reviews and approves validation protocols and reports,
* reviews and approves Marketing/Sales literature and labeling, and
* participates as a contact during external regulatory inspections for Quidel affiliates
[such as, QSR (Quality Systems Regulations), ISO (International Organization for Standardization), FDA (U.S. Food and Drug Administration), CMDR (Canadian Medical Device Regulations), IVDD (In Vitro Device Directives, EU), USDA (U.S. Dept. Agriculture), APHIS (Animal and Plant Health Inspection Services) and others, as appropriate].
O Assists in the collection and maintenance of the device Technical Files [e.g., Design History Files (DHF), Device Master Records (DMR), etc.] for appropriate documentation in accordance with applicable statutory standards and regulations.
O Interprets FDA/IVD/medical device regulations and guidelines and interacts with project teams to provide guidance and complete regulatory deliverables during the product development process.
O Evaluates change control documents for impact on regulatory submissions and filing requirements.
O Supports Clinical and Regulatory department to meet corporate objectives, by the coordination of activities, providing input into protocols and reviewing/auditing data, reports, etc., as directed.
O Complies with the requirements of Good Clinical Practice (GCP), International Council for Harmonization (ICH), FDA regulations (U.S. CFR, Code of Federal Regulations), Quality System (ISO 13485) and relevant Standard Operating Procedures (SOPs) for clinical research.
O Research regulations and competitor products and create summaries for departmental use.
O Participants on product development teams responsible for providing guidance on regulatory issues and procedural recommendations for standard operating procedures and protocols.
O Provides support and interacts with regulatory agencies with facilities inspections, licensures and permits, as directed.
O Participates in internal auditing and training systems to ensure compliance with quality system.
O Carries out duties in compliance with established business policies.
O Bachelor's degree (BS/BA) in any biological science (or equivalent combination education and/or work experience) with a minimum of 3 to 5 years' experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry manufacturing environment is required.
O RAC certificate (US, Canada, EU, Global) desirable, but not required.
O Direct interactions with FDA and other regulatory agencies preferred.
O Must have experience in the preparation and submission of regulatory documentation including, but not limited to, 510(k) submissions, licensures and international registrations.
O Strong knowledge of quality systems and good manufacturing practices (GMP) in a manufacturing environment; working knowledge of current and evolving state, federal and international regulations and procedures relevant to the approval of medical devices (current FDA, QSR, ISO, CMDR, IVDD and other worldwide regulatory regulations as appropriate).
O Ability to work cohesively with multi-disciplinary scientific working groups. Excellent written and verbal interpersonal skills to influence many diverse internal/external customer groups.
O Ability to support Clinical, Operations, and Safety departments on an as needed basis in order to meet corporate objective.
O Ability to work independently and be self-motivated. Ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner. Works on assignments of moderate scope where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
O Exercises judgment within defined procedures and practices to determine appropriate action. Acts with minimal supervision to determine methods and procedures on new assignments.
Problem solving/decision making:
O Ability to work independently and be self-motivated.
O Ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner.
O Works on assignments of moderate scope where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
O Exercises judgment within defined procedures and practices to determine appropriate action.
O Acts with minimal supervision to determine methods and procedures on new assignments.
Before you apply, please make sure you share Quidel' s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players.
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Equal employment opportunities for all employees. We fulfills this commitment through a variety of measures including internal & external posting of job openings, hiring, training & promoting individuals without regard to race, color, religion, sex, pregnancy, national origin, ancestry, citizenship, veteran status, disability, medical condition, marital or domestic partner status, sexual orientation, gender identity, age,or any other considerations made unlawful by federal,state or local law