Sr Regulatory Affairs Specialist

Sr Regulatory Affairs Specialist

Requirements

• Minimum 10 years of experience in the medical device industry, including significant experience in regulatory affairs and a proven track record in the U.S. pre-sub, 510(k) and IDE submissions.
• 3-5 years of experience as a people manager with demonstrated ability to lead, mentor, and foster a culture of continuous improvement and professional growth within a team.
• In-depth understanding of U.S. medical device regulations, EU MDR, and Health Canada regulations, coupled with strategic planning and execution of global regulatory strategies.
• Strong working knowledge of design controls, risk management, verification and validation processes, and product labeling requirements.
• Excellent verbal and written communication and presentation skills, with the ability to translate complex technical information into clear regulatory documentation and submissions.
• Strong interpersonal, negotiation, and influencing abilities, capable of engaging with senior leadership and external regulatory bodies to drive initiatives.
• Proactive in professional development and staying informed about regulatory changes, with a focus on accuracy, completeness, and driving results.

Responsibilities

• Lead and manage the regulatory affairs team within the Multiport Business Unit, providing strategic and technical guidance to ensure compliance with global regulatory requirements.
• Develop and execute regulatory strategies for new product introductions and modifications, overseeing submissions for the U.S., Canadian, and international markets.
• Act as the primary liaison between regulatory bodies and the company, facilitating communication to expedite submission reviews and approvals.
• Evaluate and interpret new regulations and guidelines, advising senior leadership on potential impacts and necessary compliance actions.
• Coordinate and lead the preparation of regulatory submissions, including 510(k) premarket notifications, Pre-subs, and Canadian license applications.
• Provide regulatory expertise during product development and design control, ensuring that documentation such as risk management and test reports meet regulatory standards.
• Mentor and develop regulatory affairs staff, fostering a culture of continuous improvement and professional growth within the team.
• Collaborate with cross-functional teams, including R&D, quality, and manufacturing, to align regulatory strategies with business objectives and facilitate successful project execution.
• Identify and mitigate regulatory risks, developing contingency plans to address potential compliance issues.
• Stay abreast of industry trends and regulatory changes, integrating new knowledge into strategic planning and operational practices.
• Perform other duties as required, contributing to the overall success of the regulatory affairs function.

Preferred Qualifications

• RAPS Regulatory Affairs Certification (RAC) is a plus.