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Regulatory Affairs Associate

Position Summary
The position of Regulatory Affairs Associate will be responsible to provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in both the U.S. and global regions. Provide regulatory support to marketed products and ensure company's regulatory compliance status.
Responsibilities
Manage regulatory databases (e.g. regulatory files, technical files, standard documentation, labeling)
Assist in preparation of regulatory submissions and strategies for US and OUS (510(k)s, technical files, design dossiers)
Manage and review, from a regulatory perspective, advertising and promotional content
Work with Regulatory Management and Regulatory Specialists to support product development teams in providing direction on regulatory requirements and strategy
Research technical requirements for regulatory databases
Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
Support the development and implementation of regulatory processes, procedures, and standards as assigned.
Monitor and review technical standards for medical devices
Support audits from regulatory bodies (e.g. FDA, notified body)
Education and Experience
Minimum Requirements:
Bachelors Degree Required, with emphasis on life science or engineering preferred.
Minimum of 0-2 years knowledge and experience with regulatory requirements for medical devices (IDE's, PMA's, 510(k)'s, CE mark technical files and design dossiers).
Good oral and written communications skills and ability to work on cross-functional teams.
Working knowledge electronic documentation and information systems.
Preferred Skills and Competencies:
Effective verbal and written communication skills
Ability to communicate at multiple levels of an organization
PC skill, word processing, spreadsheet, database
Ability to organize and manage multiple priorities
Ability to generate and maintain accurate records
Physical Requirements:
None


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