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 role will not require direct people management.

• Acts as primary core team member on product development teams and establishes regulatory strategy to achieve market clearance. 
• 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 experience.
• 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 policies.

EDUCATION/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 development teams.
• Must have prior direct interaction with FDA and other regulatory agencies.

KNOWLEDGE/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 detail.
• 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 required. 
• 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 required.
• 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.