San Diego, CA
Principle Regulatory Affairs Specialist
General Job Description:
The Principal Regulatory Affairs Specialist works as a high level independent contributor and is responsible for supporting the development and implementation of the overall objectives and long-range regulatory strategies that impact the introduction of new products, the market status of existing products and the development and maintenance of systems and processes that assure compliance with regulatory requirements. May serve as a mentor to help develop regulatory depth and knowledge within the regulatory department.
Works with senior management by overseeing the activities required to insure that products manufactured and/or distributed by the companyare in full compliance with U.S. and all applicable international regulatory requirements.
Maintains current knowledge of the developments and changes to applicable laws, regulations and industry standards.
Develops and implements regulatory strategies for new and modified products.
Provides regulatory guidance and direction as a core team member on manufacturing and development teams, throughout the product life-cycle, and identifies/coordinates cross functional deliverables for submissions.
Prepares submissions to obtain and maintain global regulatory approvals of products.
Reviews and approves device labeling and advertising & promotional materials to ensure continued compliance to global regulations; leads the development of regulatory strategies for new claims, indications and therapies.
Reviews and approves product and manufacturing changes for compliance with applicable regulations.
Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through verbal and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
Provides regulatory representation on corporate-wide projects related to product development, design controls, design assurance, sustaining engineering and regulatory business systems.
Provides expertise and guidance in interpreting regulations and agency guidelines.
Provides support for acquisitions, including due diligence and post-acquisition assessment and education.
Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
Provides support for internal and Regulatory Agency audits.
Builds Quality into all aspects of job performance by maintaining compliance to all quality requirements.
Work Environment: Office, 5% travel (very minimal)
6-8 years of regulatory experience
5% travel periodically
Top 3 requirements: 510K submissions, CLIA submissions, and IVD experience
Experience with dual submissions (510K + CLIA)
Nice to have: international submission experience, software/product implementation experience
Bachelor’s degree at least
Application Information & Contact (How to Apply)
Please contact Serina Durand at firstname.lastname@example.org