Senior Regulatory Affairs Specialist

We are NeuroVasc Technologies We deliver excellence through innovation with integrity. This On-site role reports directly to the CEO. The Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and applications. Duties and Responsibilities include • Manages and coordinates international product registration submissions, oversees status of internal regional regulatory activities; ensures compliance with relevant regulations and standards. • Leads Regulatory on Global product registrations in a timely manner to meet the needs of the business for product growth and geographical expansion. • Actively engages with cross-functional teams (as required) to plan for and provide regulatory guidance, services, and capabilities to support planned product launch and market expansion. • Coordinates (pre) submissions and approval of all applications, ensuring they are accurate and appropriate to the requirements of the regions. • Plans and tracks specified product registration and renewal activity, ensuring alignment with portfolio priorities throughout the registration and renewal processes; manages expirations / renewals and planning for new applications. • Manages and oversees relationships and interactions with Health Authorities (HAs) to ensure the company’s knowledge of requirements and expectations is current and robust; shares this regulatory intelligence with colleagues to ensure the company is informed of opportunities and risks. • Participates in any relevant regulatory improvement projects. Education and Experience: • Bachelor’s degree or higher in Life Sciences, Engineering, or related disciplines. • Minimum of 5 years’ plus experience in Regulatory Affairs. • Experience working with Class I, II and III medical devices. • Deep understanding of relevant laws, regulations, and guidelines governing the development, approval, and marketing of medical devices. • Proven knowledge of regulatory requirements and experience preparing international documents, such as STEDs, Design Dossier, and Technical Files and new products registration for Non-EU, Canada, LATAM, APAC (Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA. • Strong working knowledge of EU (MDD / MDR) medical device regulations and submissions. • Experience and proven ability in preparing US regulatory submissions e.g., IDE, 510(k), PMA, and technical documentation. • Knowledge of Quality Systems requirements such as QSR, ISO 13485, GxP. • Strong leadership and project management skills and ability to manage complex projects and timelines within a team environment. • Ability to identify compliance risks and escalate when necessary. • Demonstrated ability to stay abreast of changing regulations and standards. • Excellent computer aptitude and document formatting and publishing skills. • Strong problem-solving skills and ability to deal with changing priorities. NeuroVasc is an equal opportunity employer. Salary range - up to $150K depending on experience