Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Intellectt Inc
Temecula, CA
See who Intellectt Inc has hired for this role
Role: Senior Regulatory Affairs Specialist
Location: Temecula, CA - 92591
Duration: 08+ Months on W2
Shift Timings: 8 AM to 5 PM
Skills Looking For
Location: Temecula, CA - 92591
Duration: 08+ Months on W2
Shift Timings: 8 AM to 5 PM
Skills Looking For
- Regulatory Submission Experience: Proficiency in US (FDA) and European (CE) regulatory submissions, particularly with Class 3 devices in the US and Class 2B devices in the EU.
- Reviewing and Assessing Changes; reviewing changes and assessing their regulatory impact, including submitting to international regulatory agencies or updating internal documentation to meet regulatory requirements.
- Day-to-day Responsibilities:
- Handle the preparation, review, and submission of regulatory documents for US (FDA) and European (CE) regulatory agencies.
- Review and assess proposed changes to products or processes to determine their regulatory impact; evaluate changes for potential risks and ensure that necessary regulatory requirements are met before implementation.
- Work closely with international regulatory affiliates to provide documentation and support for new product registrations, renewals, or changes; coordinate with regulatory counterparts in other countries to ensure compliance with local regulations.
- Support the product release authorization process by ensuring that all necessary regulatory requirements are met before products can be distributed; verifying labeling compliance and submitting requests for distribution approval.
- Maintain regulatory documentation and records in accordance with regulatory requirements and internal procedures; keeping track of submission timelines, approvals, and other regulatory activities.
- Stay updated on changes to regulatory requirements and standards relevant to the medical device industry. Ensure that regulatory activities and submissions align with current regulations and guidelines.
- Bachelor's degree is required.
- The ideal candidate should have 3 to 5 years of experience in regulatory affairs. May consider candidates with 2 years ' experience if they are very strong.
- Regulatory Submission Experience: Ability to handle US and EU submissions effectively; particularly with Class 3 devices in the US and Class 2B devices in the EU.
- Analytical Thinking: Capacity to assess changes for regulatory impact.
- Multitasking: Skill in managing multiple projects with tight deadlines.
- One to Two rounds of phone/video interviews.
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Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Medical Equipment Manufacturing
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