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Sr Regulatory Affairs Specialist

Company: TechDigital Corporation
Location: Santa Clara
Posted on: November 22, 2021

Job Description:

Job Description

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 needed.

Job Description
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
expertise.
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
regulations.
Supports the product release process by completing requests for product release.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
Reviews protocols and reports to support regulatory submissions.
Support all Company initiatives as identified by management and in support of Quality Management
Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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.
General Qualifications
BA or BS degree (degree in a technical discipline highly preferred).
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 devices
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 business environment.
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 projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the
organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to maintain regular and predictable attendance.
Ability to identify and solve problems and work independently with little oversight.

Keywords: TechDigital Corporation, Santa Clara , Sr Regulatory Affairs Specialist, Other , Santa Clara, California

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