Principal Regulatory Affairs Specialist

3 weeks ago

Palo Alto, United States Planet Pharma Full time

Responsibilities and Duties: Acts as technical regulatory lead on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA, EU and international product registrations and licensing requirements. Develops global regulatory strategies for new and modified products. Prepares and submits Pre-subs/ PMA/ IDE Submissions and supplements for new products and product changes as required to ensure timely approvals for clinical studies and market release. Provide support to currently marketed products as necessary including review of labeling, promotional material, product changes and documentation for changes. Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures. Complies with U.S. Food and Drug Administration (FDA), EU and international regulations, other regulatory requirements, company policies, and governing procedures and processes. Keep abreast of changes in agency regulations and requirements, and trains stakeholders accordingly. Review and approve internal engineering documentation and change orders. Provide business and product information to international regulatory staff to enable development of strategies and requirements for global commercialization. Continuously evaluate, recommend, and implement improvements as needed.

Requirements Minimum of a Bachelors’ degree preferably in life sciences and/or biomedical engineering. Advanced degree preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). Minimum of 7 years of regulatory experience within the medical device cardiovascular industry preparing Pre-submissions, PMA submissions is required. Hardware and software regulatory experience is required. Must be able to manage multiple and competing priorities and manage programs with minimal oversight. Extensive experience at formulating successful regulatory strategies that meet established approval timelines, while maintaining the highest level of quality Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, US and major market regulatory requirements, project management, and negotiations. Experience with medical device hardware and software requirements and software regulations. Demonstrated ability to work well in dynamic and cross functional team environment. Demonstrated collaboration and leadership skills in team setting. Solid understanding of design control and change control. Experience reviewing design specifications and other technical documents. Excellent interpersonal and communication skills, both oral and written. Ability to identify risk areas and escalate issues as appropriate. Self-motivated with excellent time management skills Strong team player; willing to work collaboratively.

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