Regulatory Affairs Specialist
Posted on: November 12, 2021
Kelly Services is actively recruiting for a Regulatory Affairs
Specialist for a Direct Hire opportunity in Greater Chicago area,
IL. Kelly is seeking a Regulatory Affairs Specialist to join the
Regulatory department. The Regulatory Affairs Specialist is
responsible for supporting the preparation of regulatory
submissions and assisting international business partners with
product registrations; preparation of technical files; provide
change notifications to foreign distributors and notified bodies;
provides regulatory support to lifecycle management and new product
development/new product introduction and international product
registrations. In This Position You Will Use Your Experience To
- Under supervision, coordinate, compile, and submit regulatory
documents to competent authorities, notified bodies, regulatory
agencies, and international business partners, including the
preparation of key market international documents, including
- Work with Manager, Regulatory Affairs to ensure rapid and
timely approval of new products and continued regulatory support of
products marketed outside the United States
- Work to support and ensure regulatory compliance across LATAM
region for a broad product portfolio including medical devices,
consumer packaged goods, drugs and cosmetics.
- Assist with the development of the LATAM regulatory strategy
collaborating with appropriate functional partners and contribute
to business strategy.
- Support and make recommendations for projects by working
closely with LATAM functional partners and Manager Regulatory
Affairs to move projects from discovery to launch.
- Under supervision, evaluate proposed product modifications for
international regulatory impact, completing regulatory assessments
- Ensure compliance with applicable international regulations and
- Ensure preparation of necessary outlines, summaries, status
reports, memos, graphs, charts, tables, and slides.
- Under supervision, prepare responses to health authority
questions and other regulatory correspondence.
- Gather and assemble information necessary for submissions in
accordance with regulations and relevant guidelines.
- Update and maintain FDA/Health Canada Establishment
Registration and Listing, as well as State licensing
- Provide support to inspections/audits by government agencies
and the notified body by producing requested documents or answering
any inquiries for information.
- Review and approve promotional materials. The Ideal Candidate
- Bachelor's Degree in Science/Technology required
- Minimum of 2 years of related experience with Medical
- Direct experience with international medical
device/cosmetic/drug registration (especially Brazil, Colombia,
Argentina, Mexico, Canada and Europe) is desired
- Minimum 1 year of experience with 21 CFR 820, 807, 11, 701;
ICH, ISO 13485:2016 and ISO 14971
- Familiarity with application of US Federal Food, Drug, and
Cosmetic Act (FD&C), Section 510(k) is required.
- Experience in the application of the European Medical Devices
Directive (93/42/EEC as amended by 2007/47/EC) is required; EU MDR
familiarity is desired.
- Working knowledge of Regulatory Authority computerized
- Solid writing ability and good verbal communication skills
- Proficiency in MS Office
- Good interpersonal and organizational skills Benefits
- Comprehensive insurance coverage that includes Medical, Vision,
Life and disability insurance plans along with enhanced Dental
- Wellness program including an onsite fitness center.
- 401K retirement plan with 5% employer match (Pretax and Roth
- 401k profit sharing contribution based on company
- Paid holidays and generous paid time off.
- Competitive annual bonus and sales incentive programs Employee
- On-site caf-- featuring daily specials with dinner-to-go
- Miles of beautifully maintained walking trails.
- Numerous employee appreciation events throughout the year.
- Professional development and training classes
- Flexible schedule including work from home options If you feel
you have the knowledge and expertise, apply today to connect with a
Kelly professional who will work to enrich your life. #TJP2021_SPEC
Why Kelly -- ? Kelly-- Science & Clinical is your connection to
premier scientific and clinical companies looking to hire talented
people just like you. Every day, we match science professionals
with dream jobs that fit their skills and interests-it's the way we
think job searching should be. Nearly 100 percent of our science
recruiters have a professional background/education in science, so
we know a thing or two about the science market and how to get you
noticed. About Kelly -- At Kelly, we're always thinking about
what's next and advising job seekers on new ways of working to
reach their full potential. In fact, we're a leading advocate for
temporary/nontraditional workstyles, because we believe they allow
flexibility and tremendous growth opportunities that enable a
better way to work and live (plus, did we mention we provide a ton
of benefits ?). Connecting great people with great companies is
what we do best, and our employment opportunities span a wide
variety of workstyles, skill levels, and industries around the
world. Kelly is an equal opportunity employer committed to
employing a diverse workforce, including, but not limited to,
minorities, females, individuals with disabilities, protected
veterans, sexual orientation, gender identity. Equal Employment
Opportunity is The Law. ]]
Keywords: Kelly, Schaumburg , Regulatory Affairs Specialist, Other , Schaumburg, Illinois
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