Real

Compensation

Full Description

Our client, a global leader in neurovascular and peripheral medical technologies, is seeking a Principal Regulatory Affairs Specialist to lead worldwide product approval strategies. This role is ideal for an experienced regulatory professional who thrives in a dynamic, innovation-driven environment and is passionate about advancing life-saving medical devices to global markets. About the Company Our client is recognized for its groundbreaking medical technologies and commitment to improving patient outcomes. With a strong emphasis on research, development, and quality, the organization fosters a collaborative and high-performance culture. Team members benefit from professional growth opportunities, cross-functional leadership exposure, and the chance to contribute to products that make a meaningful impact in healthcare. Role Overview This position leads global regulatory submission strategies for neurovascular and peripheral devices, with a focus on the US, EU, and Canada. As a senior specialist, you will manage large-scale projects, mentor junior team members, and ensure compliance with FDA and international regulatory requirements. Key Responsibilities • Develop and execute global regulatory strategies for assigned projects and markets. • Represent Regulatory Affairs on cross-functional teams to ensure strategic alignment. • Coach, delegate, and review work of junior regulatory professionals. • Prepare, review, and submit regulatory filings (FDA, CE Mark, Health Canada, ROW). • Communicate with regulatory agencies and maintain detailed documentation. • Assess regulatory impact of product changes and review promotional materials for compliance. • Maintain regulatory documentation and contribute to process improvements. • Lead training initiatives for global regulatory systems and processes. • Mentor team members and foster team cohesiveness. • Ensure compliance with applicable laws, regulations, and internal quality systems. Required Qualifications • Bachelor's degree in a scientific or technical discipline. • 7-10 years of regulatory experience in the medical device industry. • Proven success with FDA Class II/III submissions, CE Mark applications, and Health Canada filings. • Direct experience communicating with regulatory authorities on strategy and submissions. • Strong technical writing and verbal communication skills. • Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook, Teams). • Ability to work onsite at least 3 days per week. Preferred Qualifications • Advanced degree in a relevant scientific or technical field. • Experience leading large project teams across multiple product lines. • Strong analytical and organizational skills. • Ability to interpret complex technical documentation and concepts. This is a unique opportunity to join a mission-driven organization at the forefront of medical innovation. If you're ready to lead global regulatory efforts and make a meaningful impact, we encourage you to apply. EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real, please visit www.realstaffing.com