Sr Regulatory Affairs Specialist
Company: TechDigital Corporation
Location: Santa Clara
Posted on: November 22, 2021
This position leads the preparation and submission of Regulatory
applications for International markets, including
supporting sustaining existing approvals. The Regulatory Affairs
Specialist acts independently to identify and resolve
problems, provides regulatory guidance to cross-functional partners
and demonstrates strategic thinking and
creativity in support of programs. This Regulatory position focuses
on assisting with International submissions, EU
MDR readiness of Regulatory files and may assist with US and EU
submissions including PMA, 510k, IDE, assessing
engineering Change Orders and assisting Regulatory team as
Prepares robust regulatory applications supporting International
geographies to achieve departmental and
organizational objectives. Supports EU MDR transition activities
and maintains product technical files.
Creates, reviews and approves engineering change order and prepare
worldwide Regulatory assessments
May act or assist as a regulatory representative on core product
development teams, communicates
regulatory requirements and impact of regulations to the
development team. Provides guidance and
May act or assist as liaison between the Company and the various
appropriate regulatory agencies,
ensuring that communications on both sides are germane, specific
and convey all necessary detail.
Maintains ongoing surveillance and analysis of all pertinent
domestic and international medical device
regulations to ensure submission requirements world-wide are
current, up-to-date and are entered into
regulatory submission data base and file systems. Ensures that
information of such regulations and
requirements, especially those that are new or modified, are
distributed to appropriate personnel.
Reviews device labeling and marketing materials for compliance with
submissions and applicable
Supports the product release process by completing requests for
Conducts reviews of product and manufacturing changes for
compliance with applicable regulations.
Reviews protocols and reports to support regulatory
Support all Company initiatives as identified by management and in
support of Quality Management
Systems (QMS), Environmental Management Systems (EMS), and other
Complies with U.S. Food and Drug Administration (FDA) and
international regulations, other regulatory
requirements, Company policies, operating procedures, processes,
and task assignments. Maintains
positive and cooperative communications and collaboration with all
levels of employees, customers,
contractors, and vendors.
Performs other related Regulatory Affairs duties and
responsibilities, as assigned.
BA or BS degree (degree in a technical discipline highly
A minimum of 5 years of technical experience, ideally having at
least 2 years of direct regulatory experience
in the medical device industry.
Working knowledge of US FDA and International Regulation of medical
Experience with international submissions and notification
processes, EU design dossier submissions, and
US submissions (510(k) applications, PMA supplements).
Experience working in a broader enterprise/cross-division business
unit model preferred.
Ability to work in a highly matrixed and geographically diverse
Ability to work within a team and as an individual contributor in a
fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish
Strong verbal and written communications with ability to
effectively communicate at multiple levels in the
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to
Ability to maintain regular and predictable attendance.
Ability to identify and solve problems and work independently with
Keywords: TechDigital Corporation, Santa Clara , Sr Regulatory Affairs Specialist, Other , Santa Clara, California
Didn't find what you're looking for? Search again!