Senior Regulatory Affairs Specialist - Irvine, United States - NeuroVasc Technologies, Inc.
Description
We are NeuroVasc Technologies We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.
Reporting 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.
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 companys 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:
Bachelors 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 is $100-$137K
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