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Regulatory Affairs Specialist 4
Job Location:
Job Location:
Mountain View, CA - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
25 June 2026 (30+ days ago)
Posted:
Application Deadline:
22 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Senior Regulatory Affairs Specialist
Location: Mountain View CA 94043
Work Arrangement: Onsite 3 Days Per Week
Work Arrangement: Onsite 3 Days Per Week
Position Summary
The Senior Regulatory Affairs Specialist is responsible for developing regulatory plans reviewing design input/output documentation identifying applicable standards and guidance documents performing regulatory assessments to determine the impact of design and process changes preparing regulatory submissions and maintaining regulatory filings and licenses.
Essential Job Duties
Provide regulatory guidance to product teams develop regulatory plans and review and approve product design control documentation.
Determine regulatory pathways and formulate regulatory strategies for the United States and Canadian markets.
Assess regulatory impact on design materials labeling packaging manufacturing processes and facility changes.
Influence and lead global regulatory strategies.
Author and lead regulatory documentation and submissions including:
U.S. FDA 510(k) Premarket Notifications
Internal Letters to File
Pre-Submissions
Health Canada Submissions
Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
Provide risk-based guidance and regulatory input to projects and issues while ensuring cross-functional alignment and resolution.
Collaborate with international counterparts to support global regulatory submissions approvals and implementation rollouts.
Required Skills and Experience
Minimum 8 years of Regulatory Affairs experience within a medical device company (experience may be combined with a Regulatory Affairs Masters degree such as a Masters in Regulatory Science).
In-depth understanding of U.S. medical device regulations Health Canada guidance and EU MDR requirements.
Working knowledge of:
Product lifecycle management
Design controls
Risk management
Verification and validation
Product labeling requirements
Ability to work in a fast-paced environment and manage multiple projects simultaneously.
Strong verbal and written communication skills with the ability to translate technical documentation into effective internal documentation and regulatory submissions.
Team-oriented mindset with a willingness to support colleagues and contribute to departmental success.
Strong interpersonal negotiation and influencing skills while maintaining a high level of professionalism.
Proactive approach to professional development and maintaining current knowledge of the regulatory landscape.
Required Education
Bachelors degree or higher in:
Biomedical Engineering
Electrical Engineering
Mechanical Engineering
Pharmacy
Non-technical degrees with equivalent complex medical device experience will also be considered.
Preferred Qualifications
Regulatory Affairs Certification (RAC) from RAPS is a plus.
Working Conditions
None specified.
Provide regulatory guidance to product teams develop regulatory plans and review and approve product design control documentation.
Determine regulatory pathways and formulate regulatory strategies for the United States and Canadian markets.
Assess regulatory impact on design materials labeling packaging manufacturing processes and facility changes.
Influence and lead global regulatory strategies.
Author and lead regulatory documentation and submissions including:
U.S. FDA 510(k) Premarket Notifications
Internal Letters to File
Pre-Submissions
Health Canada Submissions
Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
Provide risk-based guidance and regulatory input to projects and issues while ensuring cross-functional alignment and resolution.
Collaborate with international counterparts to support global regulatory submissions approvals and implementation rollouts.
Required Skills and Experience
Minimum 8 years of Regulatory Affairs experience within a medical device company (experience may be combined with a Regulatory Affairs Masters degree such as a Masters in Regulatory Science).
In-depth understanding of U.S. medical device regulations Health Canada guidance and EU MDR requirements.
Working knowledge of:
Product lifecycle management
Design controls
Risk management
Verification and validation
Product labeling requirements
Ability to work in a fast-paced environment and manage multiple projects simultaneously.
Strong verbal and written communication skills with the ability to translate technical documentation into effective internal documentation and regulatory submissions.
Team-oriented mindset with a willingness to support colleagues and contribute to departmental success.
Strong interpersonal negotiation and influencing skills while maintaining a high level of professionalism.
Proactive approach to professional development and maintaining current knowledge of the regulatory landscape.
Required Education
Bachelors degree or higher in:
Biomedical Engineering
Electrical Engineering
Mechanical Engineering
Pharmacy
Non-technical degrees with equivalent complex medical device experience will also be considered.
Preferred Qualifications
Regulatory Affairs Certification (RAC) from RAPS is a plus.
Working Conditions
None specified.
