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Manager, Regulatory Affairs
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. 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.
We are looking for a Manager of Regulatory Affairs to join our team in our Athens, Ohio location. The Regulatory Affairs Specialist will implement regulatory activities related to the approval of new IVDs and Medical Devices into the worldwide market. The Regulatory Affairs specialist will be a participant on product development teams responsible for providing guidance on regulatory issues and procedural recommendations for standard operating procedures and protocols.
· Prepares regulatory submission plans for both domestic and international submissions.
· Prepares and submits international registration dossiers, as required Pre-Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical documentation, and license applications.
· Responds to all requests for additional information to ensure timely submission approval.
· Evaluates change control activities to assess regulatory impact on submissions and filing requirements. Provides regulatory affairs assessment for change control documents to ensure compliance to regulations and notification of significant changes to the respective regulatory authority body. Provides regulatory opinion for complex or unique issues and challenges regarding registration and compliance activities.
· Reviews and approves labeling and Marketing/Sales literature. Interacts with regulatory agencies with facilities inspections, licensures and permits. Supports regulatory compliance to: QSR, ISO, CMDR, IVDD/IVDR, MDSAP, USDA and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems. Maintains, follows, and implements departmental SOPs and product Technical Documentation. Manages and prepares device listing and establishment registrations. Helps support clinical trials through coordination of activities, providing input into protocols and reviewing/auditing data.
· Reviews, interprets, and communicates FDA/international regulations and guidance documents to ensure complete and scientifically sound product submissions. Research regulations and competitor products and create summaries for departmental use.
- Develop regulatory strategies for products in development to achieve market clearance in the US and international markets.
- Provide regulatory guidance for verification and validation study protocols and reports for regulatory submissions.
- Prepares and publishes regulatory documentation for domestic (FDA) and international (e.g., Canada, EU, Brazil, Australia, Japan, etc.) product submissions and registrations.
- Secures regulatory documentation including device licenses, device listings, permits, import/export certificates and annual global registrations.
- 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/IVDR (In Vitro Device Directives/Regulations, EU) with an eye towards the new IVDR requirement, MDSAP (Medical Device Single Audit Program; US, Canada, Brazil, Australia and Japan), USDA (U.S. Dept. Agriculture), APHIS (Animal and Plant Health Inspection Services) and others, as appropriate].
- Assists in the management, collection and maintenance of the device Technical Documentation for appropriate documentation in accordance with applicable statutory standards and regulations.
- 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.
- Evaluates change control documents for impact on regulatory submissions and filing requirements.
- 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.
- 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.
- Research regulations and competitor products and create summaries for departmental use.
- Participants on product development teams responsible for providing guidance on regulatory issues and procedural recommendations for standard operating procedures and protocols.
- Provides support and interacts with regulatory agencies with facilities inspections, licensures and permits, as directed.
- Participates in internal auditing and training systems to ensure compliance with quality system.
- Supports Clinical department to meet corporate objectives.
- Carries out duties in compliance with established business policies.
EDUCATION AND EXPERIENCE
- Bachelor’s degree (BS/BA) in any biological science preferred (or equivalent combination education and/or work experience) with a minimum of 5 to 8 years’ experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry manufacturing environment is required.
- RAC certificate (US, Canada, EU, Global) desirable, but not required.
- Direct interactions with FDA and other international regulatory agencies preferred.
- Must have experience in the preparation and submission of regulatory documentation including, but not limited to, 510(k) submissions, licensures and international registrations.
- Maintain notary public certification and execute notarial services, desirable, but not required.
KNOWLEDGE AND SKILLS
- 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/IVDR, MDSAP and other worldwide regulatory regulations as appropriate).
- Ability to support Clinical, Operations, and Safety departments on an as needed basis in order to meet corporate objective.
- Ability to work cohesively with multi-disciplinary scientific working groups.
- Ability to work on multiple projects simultaneously.
- Ability to work highly independent and be self-motivated. Ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner.
- Excellent written and verbal interpersonal skills to influence many diverse internal/external customer groups.
- Possess a high degree of accuracy and attention to detail.
- Work on assignments of moderate scope where independent action and a high degree of initiative are required in resolving problems and developing recommendations
- Exercises judgment within defined procedures and practices to determine appropriate action. Acts with minimal supervision to determine methods and procedures on new assignments.
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio (desirable, but not 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.
Job posted: 2022-04-24