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Director, Regulatory Affairs

Experience Level:  Manager
Job Type:  Full-Time
Location: 

MN - Plymouth, US

Requisition ID:  3621

Summary:

The Director, Regulatory Affairs (DRA) will lead the implementation of regulatory strategies for Qorvo Biotech’s marketed and development products. She/he will lead or support regulatory activities for internal and external programs and will work closely with crossfunctional 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. She/he will be tasked to assure that Qorvo Biotech delivers on their mission to exceed customer expectations by efficiently delivering globally approved, high quality products. The successful Head RA will have the relevant expertise, experience, and motivation to drive disciplined process approaches that change and improve Qorvo Biotech’s way of working and delivering sustainable results in Regulatory Operations. The ideal candidate exemplifies high technical skills, global leadership, team development acumen, effective engagement, change management skill and the ability to work with senior management and at the C-level.

 

Frequent inter-organizational leadership across multiple functions, especially R&D, Engineering, Quality, Finance, Legal, Service, Sales and Operations. Ensures that all members of Regulatory team understands and are aligned with the Qorvo Biotech and Operations missions and objectives – and execute accordingly. Maintains effective contact and working relationships with relevant Qorvo Biotech locations and vendors worldwide. Guides the future path, growth and direction of Qorvo Biotech’s Regulatory Excellence strategy for the company.

 

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.
  • Work with external Contract Manufacturers and consultants.
  • Manage submissions for regulatory approval and related activities.
  • Develop efficient organization delivers compliance in an ever changing regulatory landscape and expedites global approvals and product availability.
  • Proactively engage with FDA and other regulatory bodies related to and ensure effective Quality Management System is optimized to meet appropriate business unit, government, and international standards/regulations for efficacy, safety, quality and compliance for the design, manufacture and service of instrument and assay relocated products.
  • Drive high-effectiveness, executive-level quarterly Regulatory Management Reviews, and prepare quarterly regulatory review for board of directors. Compensation

 

Qualifications:

  • Degree in a relevant field – BS and MS.
  • Global Regulatory leader with 5+ years relevant in-vitro Lab Diagnostics (IVD) or Medical Device/Medical Products Regulatory Affairs experience in FDA and other Global Agency/Requirements Related Regulatory Affairs.
  • Deep Regulatory experience and performance excellence with Instrument platforms, Reagents/Assays, Consumables in clinical settings. Mandatory IVD, clinical diagnostic, CLIA or similar experience is required.
  • 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.
  • 2+ years of previous, similar Sr. Manager level or above Global RA experience and responsibility in FDA Regulatory environment. Successful individual must be expert in Regulatory Compliance. Mandatory extensive experience and demonstrated performance excellence in high technical skills, global leadership, team development acumen, effective engagement, change management skill and the ability to work with senior management and at the C-level on global basis. Must understand the Global market drivers and dynamics extensively. Experience in Design Assurance, Operations Quality, Risk Management, Regulatory Compliance, and Complaints Handling and Regulatory leadership and compliance. Mandatory 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. 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.

 

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 a very engaged and inspired team environment.

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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.

Qorvo is an E-Verify Employer. For more information, please see the Right to Work and E-Verify Participation posters.

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