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Director, Regulatory Affairs

Company: CTI Education Group
Location: Plymouth
Posted on: February 18, 2021

Job Description:

Job Type: Full-Time Location: MN - Plymouth, US Requisition ID: 846 Qorvo (Nasdaq: QRVO) is All Around You! We make a better world possible by providing innovative Radio Frequency (RF) solutions at the center of connectivity. We combine product and technology leadership, systems-level expertise and global manufacturing scale to quickly solve our customers' most complex technical challenges.-- Leveraging Qorvo's innovative RF solutions, Qorvo Biotechnologies has developed a differentiated in-vitro diagnostic platform that delivers high sensitivity and accuracy to clinical laboratories and point of care settings. With the recent award from NIH, it is rapidly ramping up business infrastructure and market launch to address $10BN immunoassay and molecular testing market opportunities. It provides dynamic career growth opportunities within very engaged and inspired team environment.
This position will lead the implementation of regulatory strategies for marketed and development products. This individual will lead or support regulatory activities for internal and external programs and will work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings. RESPONSIBILITIES:

  • Support management with development and implementation of departmental strategies and policies.
  • Manage, coordinate and review regulatory submission/registration documentation for domestic and international product registrations, including the independent determination of the necessary design documentation (including language/labeling requirements) required to support each submission.
  • Interpret regulations and provide regulatory guidance and strategy to cross functions project teams.
  • Develop gap and impact assessments of changing global regulatory requirements (e.g., IVDR) and revise or drafts new documentation accordingly.
  • Compile and maintain regulatory database of regulatory information, labeling and change requirements for international registrations to support market expansion.
  • Regulatory lead on product/project teams, providing regulatory guidance with respect to product development and design control (changes and processes) and responsible for the preparation and review of associated deliverables.
  • Independently research, prepare, and present on global regulatory topics to internal and external stakeholders. Contribute to the development and implementation of regulatory strategy to mitigate risks.
  • Assure compliance with all applicable (domestic and international) regulations.
  • Monitor regulatory trends and be able to apply learnings and provide guidance or strategy related to such trends.
  • Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
  • Responsible for ensuring compliance with applicable Qorvo Biotechnologies policies and procedures across the organization. And ensuring that any individuals reporting to him/her comply with the Company's Quality Management System.
    • Degree in a relevant field (BS/MS in engineering or science ideal) with 5+ years relevant MD/IVD regulatory affairs experience (or equivalent combination education and/or work experience in another function with demonstrated transferable skills set dependent on the level of qualifications achieve.
    • IVD, clinical diagnostic, CLIA or similar experience is required
    • Must have US registration and regulatory file submission experience, including direct experience with device classification and resulting conformity assessment procedures and/or the ability to independently research these requirements & prepare recommendations for best practices
    • General working knowledge of current and evolving state, federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR, CMDR, and other worldwide regulatory regulations as appropriate and standards, e.g., ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of IVDs.
    • Prior direct interactions with Health Authorities is desirable.
    • Highly self-motivated; works on assignments of moderate scope where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
    • Exceptional writing skills and verbal interpersonal skills to influence many diverse internal/external customer groups.
    • High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently
    • Ability to work cohesively with multi-disciplinary scientific working groups.
    • Good organization, interpersonal and judgment skills to influence many diverse internal/external customer groups.
    • Proficient with Microsoft Office, including Word, Excel, PowerPoint. Because this position is part of a business unit that contracts with the US government, qualified candidates must be U.S. persons (generally a US citizen or green card holder). Individuals holding temporary visas, such as F-1 or H-1B, are not U.S. persons. MAKE A DIFFERENCE AT QORVO We are Qorvo. We do more than create innovative RF solutions for the mobile, defense and infrastructure markets - we are a place to innovate and shape the future of wireless communications. It starts with our employees. As a unified global team, we bring a commitment to excellence, growth and a passion for creating what's next. Explore the possibilities with us. We are an Equal Employment Opportunity (EEO) / Affirmative Action employer and welcome all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, military or veteran status, physical or mental disability, genetic information, and/or any other status protected by law.

Keywords: CTI Education Group, Plymouth , Director, Regulatory Affairs, Executive , Plymouth, Massachusetts

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