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Lead Regulatory Affairs Consultant
2 months ago
Position: Lead Regulatory Affairs Consultant
- Contract Duration: 12+ months
- Compensation: Up to $115/hr
Key Responsibilities:
- The Lead Regulatory Affairs Consultant will leverage expertise in scientific, regulatory, and commercial aspects to ensure that i-STAT branded products comply with the necessary regulations in both the US and EU.
- This role involves significant influence at the site/divisional level and is recognized as a key resource for international regulatory standards within the division.
- The consultant will participate in cross-functional projects that support product launches, market expansion, and compliance initiatives.
- Responsibilities include analyzing regulatory requirements, gathering necessary data, and presenting this information effectively for product registration in the US and EU.
- On-site presence is required during standard business hours.
Core Duties:
- Compile and maintain submissions for US 510k and EU IVDR Technical Files.
- Ensure adherence to Corporate and Divisional Policies within the quality management system.
Additional Responsibilities:
- Prepare and review regulatory submissions for the US and EU markets.
- Identify potential regulatory challenges and collaborate with teams to develop solutions.
- Provide regulatory insights for product lifecycle management.
- Track the status of applications under review and communicate updates to stakeholders.
- Submit necessary reports and ensure timely responses to regulatory authorities.
- Utilize technical expertise to propose strategies for complex regulatory issues.
- Evaluate the acceptability of quality, preclinical, and clinical documentation for submissions.
- Assess the impact of design changes on registration in relevant regions.
- Offer strategic regulatory guidance to development teams.
- Ensure that external communications comply with regulatory standards.
Leadership Responsibilities:
- Provide leadership in projects without direct authority.
- Guide both exempt and non-exempt personnel in their regulatory assignments.
Accountability:
- Manage technical and scientific regulatory activities independently.
- Meet deadlines with minimal oversight from management.
- Effectively communicate with regulatory agencies.
- Interpret and apply regulatory requirements accurately.
- Work autonomously while achieving desired outcomes.
- Recognized as an expert in regulatory affairs.
Qualifications:
- Bachelor's Degree in a relevant scientific field is preferred; advanced degrees are advantageous.
- Certification in regulatory affairs is a plus.
Experience:
- Minimum of 5 years in a regulated industry, such as medical devices or pharmaceuticals.
Preferred Skills:
- Hands-on experience with US 510k submissions or EU MDR/IVDR technical files.
- Experience leading cross-functional teams on regulatory projects.
Benefits:
- Comprehensive Medical, Vision, and Dental Insurance Plans
- 401k Retirement Plan
About GTT, LLC:
GTT, LLC is a subsidiary of Chenega Corporation, providing Total Talent Solutions and staffing services globally. With a commitment to diversity and inclusion, we partner with leading organizations across various sectors. Our clients include Fortune 500 companies and prestigious institutions, ensuring a dynamic work environment with numerous opportunities for professional growth.
