Regulatory Affairs Specialist
Posted on: November 19, 2021
Medical Device Manufacturing
Responsible for regulatory affairs activities to assist in
regulatory submission, annual reports, registrations and listings.
Assure compliance with applicable medical device regulations per
jurisdiction, guidance and standards. Assist in creation and
maintenance of regulatory files.
Reports to: Regulatory Affairs Manager
- Write, analyze, and edit technical documents to support
countryspecific regulatory submissions and compile submissions in a
format consistent with applicable guidance documents, including
investigational device submissions in USA, Canada and Europe. Work
with other departments and communicate the submission requirements
when documents are needed for regulatory submission.
- Maintain regulatory files. Maintain and update regulatory
authorizations, such as IDEs, 510(k)s, Canadian medical device
licenses, and CE dossiers for EU, NRTL certifications etc. Assure
that appropriate maintenance of registrations occurs including
renewals, device listings, site registrations, supplements for
changes and annual reports. Support approval in other regions as
- Assist in preparing response to regulatory authorities
questions within assigned timelines.
- Stay abreast of regulatory procedures and changes in regulatory
- Assess device related incidents/complaints for medical device
reporting requirements. Compile and submit reportable events to
relevant regulatory authorities in timely manner. Handle recalls
and field actions, if required.
- Review and create product labels and review promotional
material for compliance with applicable regulations and technical
- Support external regulatory agency audits, providing regulatory
input to minimize potential for findings of non-compliance.
- Assist in preparing clinical trial site ethics review board
applications for investigational device trials. Prepare interim or
final reports for trial site ethics boards as required
- Other duties as assigned.Requirements
- Bachelor's degree or equivalent in Engineering or Science or
related scientific discipline, or equivalent. Higher degree MS/PhD
will be an advantage.
- Minimum of 3 years regulatory or equivalent experience within a
device or pharmaceutical company, CRO, or similar
- Scientific knowledge, must be able to digest complex data while
keeping the big picture through good analytical skills.
- Excellent written and Verbal communication skills with the
ability to listen, articulate and advocate.
- Proactive, high performance, result oriented and manage
projects with ethical integrity.
- Technical system skills (e.g. MS office applications,
databases, efficient online research).
- Manage multiple projects and deadlines.
- Ability to identify compliance risks and escalate when
- Demonstrate both creative and critical thinking skills.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
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