Regulatory Affairs Manager Remote
Location: Salt Lake City
Posted on: September 25, 2022
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. We are a leading
manufacturer of point of care diagnostic solutions. 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.
We are excited to announce that Quidel Corporation is now becoming
QuidelOrtho! This transaction will bring together two world-class
teams and complementary product portfolios to serve patients around
the world. During this transition period, we encourage you to
continue visiting our career site and also check out more career
opportunities at Careers at Ortho Clinical Diagnostics - Ortho
Clinical Diagnostics jobs Join our journey as we become one global
We are looking for a remote Regulatory Affairs Manager to join our
Regulatory Affairs team. The Regulatory Affairs Manager implements
regulatory activities related to the approval of new IVDs (in vitro
diagnostics) and medical devices into the worldwide market, as
directed. Participates on product development teams and provides
guidance and strategies for regulatory issues. Interacts with
regulatory agencies regarding product registrations, licensures and
permits, and supports regulatory compliance to QSR, ISO, CMDR,
MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements.
Reviews and approves labeling and Marketing/Sales literature.
This position operates from roughly 8:00 am - 5:00 pm Pacific
Standard Time, Monday - Friday.
- Acts as primary core team member on product development teams
and establishes regulatory strategy to achieve market
- Reviews and approves verification and validation study
protocols and reports for regulatory submissions.
- Prepares and publishes regulatory documentation for domestic
(FDA) and international (e.g., Canada, EU, etc.) product
submissions and registrations and secures approval.
- Acts as official correspondent with government agencies for
regulatory submissions, depending upon capabilities and level of
- Supports corporate regulatory compliance activities including:
provides regulatory guidance, reviews and approves validation
protocols and reports, reviews and approves Marketing/Sales
literature and labeling, and acts as subject matter expert 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].
- Establishes and/or owns regulatory affairs processes and acts
as subject matter expert during inspections.
- Develops and presents training materials for regulatory
requirements and/or department processes.
- Assists in the maintenance of Technical Files in accordance
with applicable statutory standards and regulations.
- Evaluates change control documents for impact on regulatory
submissions and filing requirements, as needed.
- Supports department to meet corporate objectives by
coordinating activities, providing input into protocols, and
reviewing/auditing data, reports, etc., as directed.
- Researches regulations and competitor products and creates
summaries for departmental use.
- Provides support for facilities inspections, licensures and
permits, as needed.
- Participates in internal auditing and training systems to
ensure compliance with quality system, as needed.
- Carries out duties in compliance with established business
EDUCATION AND EXPERIENCE
- Bachelor's degree (BS/BA) in a scientific discipline is
required; BS/BA in a biological science is preferred.
- Minimum of 8 years' prior experience in the IVD (in vitro
diagnostic), medical device or bio/pharma industry manufacturing
environment is required; minimum of 5 years' experience in the IVD
or medical device manufacturing environment is preferred.
- Minimum of 8 years' prior experience in Regulatory Affairs (or
related educational/work experience) with progression of
responsibility and leadership is required.
- Must have prior experience in the preparation and submission of
regulatory documentation including, but not limited to, 510(k)
submissions and international registrations.
- Must have prior experience as a core team member on product
- Must have prior direct interaction with FDA and other
KNOWLEDGE AND SKILLS
- Advanced knowledge of quality systems and good manufacturing
practices (GMP) in a manufacturing environment is required
- Strong 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) is required.
- Ability to work cohesively with multi-disciplinary scientific
working groups is required.
- Excellent written and verbal interpersonal skills to influence
many diverse internal/external customer groups is required.
- Must possess a high degree of accuracy and attention to
- Ability to support Clinical, R&D, V&V, and PMO
departments on an as needed basis in order to meet corporate
objectives is required.
- Ability to work independently and be self-motivated is
- Ability to work under minimal supervision following established
procedures is required.
- Ability to handle inter/intradepartmental issues in a
cooperative and diplomatic manner is required.
- Ability to work on assignments of moderate scope where
independent action and a high degree of initiative is needed in
resolving problems and developing recommendations is required.
- Ability to work on multiple projects simultaneously is
- Ability to exercise judgment within defined procedures and
practices to determine appropriate action is required.
- Proficiency with Microsoft Office, including Word, Excel,
PowerPoint, and Visio, is required.
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.
Keywords: Quidel, Salt Lake City , Regulatory Affairs Manager Remote, Executive , Salt Lake City, Utah
Didn't find what you're looking for? Search again!