Senior Regulatory Affairs Specialist

  • Full Time
  • Hybrid - 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 a SENIOR REGULATORY AFFAIRS SPECIALIST to join our team in Irvine!

What we’re looking for:

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:

Reporting to the Director of Regulatory Affairs, our Sr. RA Specialist will be responsible for developing strategies for international regulatory approval to introduce new products to market, maintain existing products registration, provide advice on regulatory requirements, and prepare worldwide submissions.

This role will support both; direct registration efforts and registration efforts made on behalf of the company by a qualified third party (i.e., Distributor). The Senior Regulatory Affairs Specialist will provide regulatory direction to team members consistent with the company’s values, quality policy, and procedures.

Provide strategic regulatory guidance to project team members, both within the organization and with a diverse range of external groups. Works independently to represent regulatory affairs in project teams*
Provide regulatory support for new products/therapies or changes to existing products. Works with engineers and technical experts to address questions from regulatory agencies.*
Prepare 510(k), IDE, PMA, Technical files, GSPR, and product registration in LTAM and APAC countries.*
Renew and maintain local, state, and national regulatory licenses and registration.*
Working knowledge of regulations assigned in each country in which products are registered and distributed.*
Maintains proficiency in worldwide regulatory requirements. Maintains, interprets, and distributes updated information regarding worldwide regulations, guidelines, and standards to management.*
Change assessment to product design specifications, or product manufacturing processes
Review and approve labeling, marketing, and promotional materials. *

What you’ll need:

Bachelor’s degree in a scientific discipline, with a minimum of 4 years of experience in the medical device industry.
Working knowledge of FDA’s GMPs (QSR), ISO 13485, MDD 93/42/EEC, MDR 2017/745, Health Canada MDR
Strong problem-solving competency
Ability to effectively manage multiple projects and priorities
Ability to interpret regulatory requirements, guidance documents, and regulations.
Effective communication and interpersonal skills.
Independent self-starter: manages time effectively and completes tasks on time with minimal supervision. Flexible and able to self-manage multiple priorities.

Extras:

Prior experience in International Medical Device regulatory affairs preferred
Regulatory Affairs Certification, preferred
Medical device regulatory submissions writing, and technical writing experience preferred.

NeuroVasc is an equal opportunity employer.

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