Regulatory Affairs Specialist
Posted on: November 22, 2021
Regulatory Affairs Specialist Role with a World-Class Medical
Device Company!! Regulatory Affairs Specialist Duties and
- Support new product development and commercial programs by
interacting with cross-functional project teams in the preparation,
review, and completion of global regulatory strategies and required
documentation to support global regulatory submissions.
- Focus on authoring, maintenance, and tracking of dossiers for
submission to global regulatory agencies including FDA premarket
notifications [FDA 510(k)], EEU Technical Files, Health Canada,
APAC, and Latin America licenses.
- Preparation, review, and completion of global regulatory
strategies for establishing and maintaining quality system
compliance to global regulations, directives and standards
including FDA QSR, 93/42 EEC, ISO 13485, MDSAP, Health Canada,
ANVISA, INMETRO, NMPA, and other countries in Latin America and the
- Maintain a working knowledge of computer software packages
including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe,
SharePoint and LOA request system, eCTD, and others as required.
Regulatory Affairs Specialist Requirements:
- Bachelor's Degree in Life or Natural Science (or equivalent)
- Experience in FDA and Global cGMP, and other regulatory
- 5+ years of experience in QA/RA with a demonstrated progression
in leadership experience in the Medical Device or Pharmaceutical
- Effective verbal and written communicator.
- Technical expertise in quality control, quality systems,
quality assurance, manufacturingtechnologies, and product function
as well as governing laws and regulations.
- Proven experience and success record with global regulatory
interactions and affairs including USA, EU MDR, ISO 13485/MDSAP,
Latin America, and APAC region regulations. Regulatory Affairs
- Medical, Dental, Vision, 401k, life insurance, short-term and
long-term disability ***For more information on this opportunity,
contact Millisa Reynolds directly at **Resumes may be
confidentially emailed to Medical Device Companies: If your team
needs any position(s) filled, we can also assist in finding
qualified talent. Contact Millisa directly or All qualified
applicants will receive consideration without regard to race, age,
color, sex (including pregnancy), religion, national origin,
disability, sexual orientation, gender identity, marital status,
military status, genetic information, or any other status protected
by applicable laws or regulations.GPAC (Growing People and
Companies) is an award-winning search firm specializing in placing
quality professionals within multiple industries across the United
States for the past 31 years. We are extremely competitive,
client-focused and realize that our value is in our ability to
deliver the right solutions at the right time.
Keywords: GPAC, Philadelphia , Regulatory Affairs Specialist, Other , Philadelphia, Pennsylvania
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