FDA Regulatory Associate
Company: Novocure Inc
Location: Fort Collins
Posted on: January 24, 2023
Job Description:
Description:
Mid-Level FDA Regulatory Associate
JOB SUMMARY:
The Mid-Level FDA Regulatory Associate will be part of the Legal
team, and will support the VP, Lead Regulatory Counsel, who is
broadly responsible for providing the business with strategic
advice and counsel on regulatory issues. The Associate will also
support the Global Regulatory Affairs function with US FDA
regulatory expertise in support of obtaining and maintaining
clinical and commercial regulatory approvals in alignment with
business objectives. The Associate will work closely with the
Global Regulatory Affairs function, providing guidance and
expertise in support of US regulatory product submissions. In
addition, the Associate will play an important role in developing
regulatory infrastructure and documentation templates to support
regulatory processes.
This is a full-time, remote position, reporting to the Vice
President, Lead Regulatory Counsel.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Be an integral member of the Lead Regulatory Counsel's team,
which is broadly responsible for providing the business with
strategic advice and counsel on regulatory issues and providing the
Global Regulatory Affairs function with US FDA regulatory expertise
in support of obtaining and maintaining regulatory
approvals.
- Under the direction of the Lead Regulatory Counsel, liaise with
other business functions as needed (Clinical, Medical Affairs,
Quality Assurance, Clinical Operations, Marketing) to provide
regulatory affairs and regulatory sciences guidance throughout the
product development cycle.
- Hands on drafting and review of US FDA filings for the
company's commercial devices and investigational devices under
clinical study, including pre-submissions and postmarket approval
reports.
- Provide regulatory-based scientific and statistical input in
the planning and design of clinical studies (including feasibility
studies), premarket clinical studies and postmarket studies in
support of US FDA marketing applications.
- Help facilitate cross-functional team inputs for regulatory
submissions.
- Support the Lead Regulatory Counsel in the assessment of
regulatory pathways for new products and product
modifications.
- Remain current on regulatory issues/trends affecting the
business, assessing and communicating their impact to colleagues,
product development/support teams, and to others in the
business.
- Under the direction of the Lead Regulatory Counsel, assist in
the creation or updating of regulatory standard operating
procedures, work instructions, and policies to ensure compliance
with regulatory and clinical study-related activities
QUALIFICATIONS/KNOWLEDGE:
- Advanced degree in life sciences, health technology, law or
engineering (MS, MPH, JD, etc.)
- Biostatistics proficiency, including use of statistical
programs, a plus
- Seven (7) years of experience in the Life Sciences
industry
- Minimum of five (5) years of directly-related professional
experience (US Regulatory) in the medical device field, in
increasingly responsible positions
- Substantial experience with the regulation of class III medical
devices in the US
- Extensive knowledge of US medical device regulations, 21 CFR
Part 812 governing investigational devices, related standards, FDA
guidance documents and Good Clinical Practice standards
- Demonstrated success in the preparation and submission to FDA
of premarket and postmarket regulatory submissions (PMAs, HDEs,
IDEs, annual reports), including pre-submissions.
- Experience working and communicating with the US FDA's Center
for Devices and Radiological Health (CDRH)
- Demonstrated cross-functional collaboration and teamwork
skills
- Demonstrated ability to understand advanced
technical/scientific principles that relate to complex products and
processes
- Demonstrated ability to provide technical review of data or
reports that will be incorporated into regulatory submissions to
ensure scientific rigor, accuracy, and clarity of
presentation
- Superb attention to detail and excellent communication
skills
- Collaborative and independent working style
- Ability to organize, plan and adjust work assignments while
meeting deadlines
- Eager to learn and learn quickly
- Excellent English (written and spoken); other European
languages an advantage
- Office software proficiency
- Fluent in English and preferably German, both written and
spoken; any further languages are of benefit
OTHER:
- Ability to lift up to 20 pounds
Novocure is taking a responsible approach to creating environments
that allow us to strive to extend survival in some of the most
aggressive forms of cancer by developing and commercializing our
innovative therapy.
As part of our commitment to health and safety COVID-19 vaccines
are required for our current U.S. employees. As an Equal
Opportunity Employer and it is our policy to provide reasonable
accommodations to any qualified individual who because of a medical
condition or sincerely held religious belief or practice receives
an exemption from the vaccination requirement, provided that such
accommodation would not result in an undue hardship for the
company. For more information regarding the Novocure's COVID
vaccination requirement, exemptions, and verification of
vaccination status please ask the Talent Acquisition team.
ABOUT NOVOCURE:
Our vision
Patient-forward: aspiring to make a difference in cancer.
Our patient-forward mission
Together with our patients, we strive to extend survival in some of
the most aggressive forms of cancer by developing and
commercializing our innovative therapy.
Our patient-forward values
- innovation
- focus
- drive
- courage
- trust
- empathy
#LI-TC1
#LI- Remote
#LI-REMOTE
Keywords: Novocure Inc, Fort Collins , FDA Regulatory Associate, Other , Fort Collins, Colorado
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