Regulatory Affairs Specialist
3 weeks ago
We are NeuroVasc Technologies, a company that delivers excellence through innovation with integrity.
This role is on-site and reports directly to the CEO. The Senior Regulatory Specialist is responsible for planning, directing, and coordinating global product registrations and leading regulatory submissions planning and execution. They collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and applications.
Key Responsibilities:- Manage and coordinate international product registration submissions, oversee the status of internal regional regulatory activities, and ensure compliance with relevant regulations and standards.
- Lead regulatory on global product registrations in a timely manner to meet the needs of the business for product growth and geographical expansion.
- Actively engage with cross-functional teams to plan for and provide regulatory guidance, services, and capabilities to support planned product launch and market expansion.
- Coordinate (pre) submissions and approval of all applications, ensuring they are accurate and appropriate to the requirements of the regions.
- Plan and track specified product registration and renewal activity, ensuring alignment with portfolio priorities throughout the registration and renewal processes; manage expirations/renewals and planning for new applications.
- Manage and oversee relationships and interactions with Health Authorities to ensure the company's knowledge of requirements and expectations is current and robust; share this regulatory intelligence with colleagues to ensure the company is informed of opportunities and risks.
- Participate in any relevant regulatory improvement projects.
- 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 is $100-$150K.
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