International Regulatory Specialist

  • Full Time
  • Irvine
  • Posted 2 months ago
  • Must be authorized to work in the U.S.A. Will you now or in the future require VISA sponsorship?

NeuroVasc is seeking an INTERNATIONAL REGULATORY SPECIALIST to join our team in Irvine!

What we’re looking for:  (This role is remote)

Collaborative partners who play well with others, interdepartmental and cross functional, team members who are NOT quick to jump to conclusions. Those who give others the benefit of the doubt while they gather all the facts.
Active Listeners who build relationships and unite team members, those who seek resolution at all costs. Team members who work together, sharing ideas and driving continuous improvement in all areas.
Problem solvers who go beyond identifying and fixing the problem, team members who look for ways to prevent future issues by identifying the root cause and seeking to improve current solutions.
Dedicated Doers, who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Inspired innovators, who are passionate about researching, developing, and executing.
Strategic thinkers, team members who continually look for opportunities to make things better, processes and beyond.
Detailed documenters, people who understand the end game, of positive patient outcomes. Everything we do is to better our patient’s quality of life. Every plan and report.
Accountable Initiators who take ownership of their work (errors too), persistently striving for resolution. Team members who drive productivity and positive change.

What you’ll do:

The International Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead international submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and applications. This role will participate in the development of regulatory input to portfolio strategy, and regional execution of portfolio plans.

Manages and coordinates international product registration submissions, oversees status of internal regional regulatory activities; ensures compliance with relevant regulations and standards.*
Works with the regulatory team at NeuroVasc on Global product registrations in a timely manner to meet the needs of the business for product growth and geographical expansion.*
Actively engages with Product Regulatory colleagues, Marketing, Sales, Supply Chain, and other internal functions (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.
Other duties as required.

What you’ll need:

Bachelor’s degree or higher in an appropriate discipline
Minimum of 2 years’ experience in Regulatory Affairs
Experienced in the skillful preparation of product technical documentation
Proven knowledge of regulatory requirements, and prior experience working with regulatory agencies; Latin America regional knowledge a plus
Experience with Class I, II and III medical devices.
Demonstrated experience supporting major regulatory submissions (ANVISA, Cofepris)
Project management and leadership experience
Strategic and operational planning strengths; able to convert high level concepts to actionable plans, confident in the selection and assignment of appropriate tools and resources.
Active participation in leadership and executive-level environments; confident to advocate and negotiate from a strong point of view.
Highly skilled at building and maintaining effective and productive relationships with key stakeholders; ability to engage with multiple stakeholders while ensuring alignment, commitment, and compliance.
People management and oversight capability, both with direct reports and influencing colleagues from other teams.
Positive, self-motivated, detailed, and hands-on, with the ability to work independently as well as collaboratively across the enterprise.

NeuroVasc is an equal opportunity employer.

 

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