Director, Regulatory Affairs
Company: CTI Education Group
Posted on: April 3, 2021
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
- 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
- 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
- Assure compliance with all applicable (domestic and
- 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
- 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
- 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
- Prior direct interactions with Health Authorities is
- 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
- 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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