Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist page is loaded## Principal Regulatory Affairs Specialist locations:
Eden Prairie, Minnesota, 55344, USAtime type:
Full time posted on:
Posted Yesterday job requisition idWe care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way.  Each member of the Bracco Medical Technologies team has the power to make a difference......every day!

The
** Principal Regulatory Affairs Specialist
** is responsible for developing and implementing regulatory strategies across projects, processes, and/or products. This individual partners with internal stakeholders and external consultants to optimize and execute these strategies in support of business objectives. This role provides hands-on regulatory affairs support for new product marketing submissions and changes to existing devices, including development of regulatory requirements/strategies and preparing submissions. In addition, this individual will represent BMT Regulatory in interactions with US and international regulators during submission reviews/approvals and audits.

This individual will ensure compliance with required regulations and established corporate standards and ensure that product approvals are properly maintained. This position requires creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks to drive successful outcomes.
** Primary

Duties & Responsibilities:

*** Develop and execute regulatory plans and author 510(k) Premarket Notifications, EU MDR Technical Documentation, Canadian Licensing Submissions, and contribute content to Japan and China submissions.
* Coordinate cross-functional support for worldwide registrations for global product growth and market expansion.
* Participate as regulatory representative on project teams throughout the product lifecycle, provide strategic regulatory direction and communicate global regulatory requirements and strategy to project teams and cross-functional partners.
* Review, edit and approve project documentation as the active regulatory representative on project teams.
* Communicate with government regulatory agencies and Notified Bodies; prepare for and lead meetings / teleconferences with external regulatory authorities, including the FDA, and support audits and inspections as assigned.
* Maintain all regulatory files ensuring documentation and registrations are complete and up to date.
* Mentor, develop, and provide oversight of junior regulatory staff and provide training and guidance for cross-functional partners.
* Contribute content for and review all forms of device labeling and advertising materials for compliance with FDA submissions and applicable global regulations; analyze and recommend appropriate changes.
* Serve as the primary point of contact with external regulatory consultants, when applicable, coordinating their contributions and ensuring alignment with internal regulatory strategies and timelines.
** Qualifications (Knowledge, Skills & Abilities):
**** Minimum
* ** Bachelor’s degree
* Minimum of 7+ years of experience in Regulatory Affairs
* Minimum of 6 years medical device industry experience including strong 510(k) submission experience, EU CE Marking, and Health Canada submissions
* Understanding of FDA, EU MDD and MDR, Australia and Canada regulatory framework including how to comply with standards and regulations
* Effective written and verbal communication skills, technical writing and editing skills necessary for high-quality regulatory submission documents
* Proven track record of successfully leading FDA meetings, such as pre-submissions and submission issue request meetings
* Ability to develop clear, concise, and timely oral and written reports
* Ability to communicate complex information and regulatory decisions tactfully to all levels of personnel
* Ability to explain technical materials concisely to audiences of varying degrees of familiarity
* Ability to solve complex problems through the application of critical thinking skills
* Effective research and analytical skills
*…