Principal Regulatory Affairs Specialist
Company: Draeger Medical Systems, Inc.
Posted on: June 21, 2022
Principal Regulatory Affairs Specialist - Draeger Medical
Systems, Inc. - Job-ID V000006500
The Job Responsibilities
- Manages and maintains worldwide country registrations and
regulatory databases for DMSI product portfolio. Reviews US and
international standards and regulations for applicability to the
Draeger product portfolio.
- Determines and communicates requirements and options for
regulatory submissions, approval pathways, and compliance
activities, and provides regulatory support and guidance throughout
the product lifecycle.
- Prepares, updates and maintains product regulatory submissions
(510(k), Technical Files, Canadian Licenses and International
- Drives RA focused projects and acts as project lead where
required. Develops and/or improves development processes,
procedures and protocols that assist in meeting internal SOP's, FDA
and industry regulations.
- Participates in cross functional teams providing
recommendations and guidance to ensure products meet regulatory
requirements. Creates/approves assigned Regulatory deliverables for
- Evaluates impact of product changes to regulatory submissions
worldwide, documenting regulatory decisions and
communication/actions required for impacted regions.
- Manages requests from regions and countries, provides responses
and requested documentation (CFG's, certifications, document
legalization, etc.) in a timely manner.
- Collaborates with parties such as EU notified body officials,
consultants, and government agencies including the FDA in support
of product approvals and audits.
- Reviews, approves and provides guidance for labeling and
advertising. Ensure proper facility registrations and device
listings for DMSI with appropriate regulatory agencies.
- Performs other duties as needed and assigned.
Education:BA/BS degree in business, engineering, medical or
- 10+ years of regulatory experience in the Medical Device
Industry. Experience in preparing and submitting Class II medical
device marketing applications to regulatory agencies
Special Competencies or Certifications:
- Master's degree in Regulatory Affairs and Quality Assurance or
Regulatory Affairs Certification (RAC) a plus
- In depth knowledge of U.S. and International regulatory
requirements for medical devices including ISO 9001, ISO 13485, EU
MDD & MDR, J-GMP and 21 CFR part 820
- Project management experience a plus
- Internal/External Audit experience a plus
- Strong interpersonal, written and oral communication
- Strong computer skills and knowledge of databases
The Dr--ger Workplace
In North America, Draeger employees over 1,400 employees working in
our major sites in the United States and Canada (in the US:
Andover, MA; Telford, PA; Houston / Coppell, TX, and in Canada:
Mississauga, ON), including our Sales and Service workforce
employees from coast to coast.Our US headquarters located north of
Philadelphia in Telford, Pennsylvania is our US manufacturing site
for our Neonatal product line supplying many global customers as
well as production support for Draeger's Safety products. This
location also serves as the key site for essential US functions
which includes Medical Sales and Service Management, Medical
Marketing, Legal, Compliance, Regulatory, Quality and Finance.Equal
Opportunity Employer - Disability and Veteran
Who we are
Draeger is a leading international company in the fields of medical
and safety technology. Whether in clinical applications, in
industry, mining or emergency services: Draeger products protect,
support and save lives. That's what our more than 15,000 employees
have been striving for - every day for more than 130 years. Dr--ger
- Technology for Life -
What we offer
- Health center and gym
- Health Insurance
- Time Away
- Special Assistance
- Additional/Voluntary Insurance
- Education & Training
- Workplace Wellness
- Retirement Savings
If you have any questions, please contact
Keywords: Draeger Medical Systems, Inc., Bethlehem , Principal Regulatory Affairs Specialist, Other , Telford, Pennsylvania
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