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Regulatory Affairs Specialist
2 weeks ago
Overview
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.
Job Responsibilities
- Write, analyze, and edit technical documents to support regulatory submissions and compile submissions in a
format consistent with applicable guidance documents. - Communicate the submission
requirements when documents are needed for regulatory
submission. - Maintain and update regulatory
authorizations, medical device
licenses, and dossiers. - Assure
that appropriate maintenance of registrations occurs including
renewals, device listings, site registrations, supplements for
changes and annual reports. - Assist in preparing response to regulatory authorities questions
within assigned timelines. - Stay abreast of regulatory procedures and changes in regulatory
climate. - 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
standards. - Support external regulatory agency audits, providing regulatory
input to minimize potential for findings of non-compliance.
Bachelor's degree or country equivalent in Engineering or Science or
related scientific discipline, or equivalent.
Skills and Requirements
- Minimum of 2 years regulatory or equivalent experience within a
device or pharmaceutical company. - Scientific knowledge, must be able to digest complex data while
keeping the big picture through good analytical skill.s - Excellent written and Verbal communication skills with the ability to
listen, articulate and advocate. - 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 necessary.
- Demonstrate proactiveness,creativity, critical thinking skills andd integrity.
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