Director, Regulatory Affairs
Company: Gateway Recruiting, INC.
Location: Santa Clara
Posted on: May 10, 2022
Job Descriptionjob summary:In this role, the Director will have
the opportunity to develop, implement and lead both regional and
international strategies for assigned projects with various
cross-functional teams. You will execute regulatory strategies for
the earliest possible approvals of the company's regulatory
applications at all stages of development and post-approval,
provide guidance for, and contribute to, the development of
documents for regulatory agencies (e.g., IDE/PMA/510k/EU
submissions), as well as ensuring that they meet current regulatory
requirements and industry standards, are high quality, consistent,
complete, and approvable on the first review cycle. This position
manages others within the Regulatory Affairs group.Provide
regulatory advice on US, EU, and global requirements
- Provide strategic regulatory input on both developmental and
- Manage submission strategies for all structural intervention
regulatory projects and prepare regulatory project plans and
- Proactively identify project issues and implement appropriate
regulatory strategies to mitigate risks
- Review documents for submission to ensure consistency with
company and submission strategy and compliance with regulatory
- Ensure and lead proper FDA interactions on key projects
- Support the preparation and conduct of Agency meetings as
necessary to support regulatory filings
- Coordinate regulatory department meetings and perform other
project management activities for the structural intervention RA
department (goal setting, meeting minutes, routine submission
tracking including regulatory commitments, deliverables, submission
- Interface with other functions of the company, including other
members of the regulatory affairs team, quality assurance, clinical
operations, clinical development, medical affairs, business
development, and program management.
- Develops, monitors, and appropriately adjusts the annual budget
for department cost center(s).
- Provides appropriate level of cross-functional and
customer-oriented communications regarding the status of department
and quality system operation, as well as product performance.
- Development of staff by setting an example, providing guidance,
work direction, corrective action, and offering counsel.EDUCATION
- Bachelor's Degree in Engineering, Sciences, or related
- 10+ years of related work experience in a similar role,
including PMA approval experience and/or knowledge of FDA
regulations, practices, and procedures.
- 2+ years in a leadership/direct supervision role
- Demonstrated experience building strategic partnerships to
further departmental and organizational objectives.
- Ability to work within a team environment and/or as a senior
individual contributor leveraging and/or engaging others to
accomplish projects within a fast-paced, matrixed environment.
- Strong verbal and written communication with the ability to
effectively communicate at multiple levels in the
- Proficient with MS Office (Word, Excel, Outlook)PREFERRED:
- Advanced degree in Engineering, Sciences, or related
- Experience working with Class III medical devices
- EU MDR submission experiencePowered by JazzHRVKp3ahJvVD
Keywords: Gateway Recruiting, INC., Santa Clara , Director, Regulatory Affairs, Executive , Santa Clara, California
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