Principal Regulatory Affairs Specialist
Principle Regulatory Affairs Specialist
Top 3 requirements: 510K submissions, CLIA submissions, IVD experience
Nice to haves: U.S. and International submission experience
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 company are 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.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.