Orange County, United States
$75,000 - $100,000
about 1 year ago
Tired of working within large corporations where you don’t get the opportunity to work on all aspects of the regulatory process? Wanting to be the part of a medical devices regulatory team working on not only domestic regulations, but also international?
Well if you answered yes to any of the above questions, then this growing medical devices company in San Bernardino have just the opportunity for you!
This person will have an understanding of regulations to help develop RA strategy for new products and changes to marked products and participate in new product development meetings, activities and support International and domestic registrations, such as Technical File, Design Dossier, 510k(k), IDE, and PMA. The Senior Regulatory Affairs Specialist will assume responsibility for the independent preparation and submission of international product registrations for ROW (rest of world) countries, including Canada. Additionally, the person in this role is responsible for assessment of device changes for regulatory implications and performing regulatory activities in support of implanting these device changes. Develops and maintains solid working relationships with other organizational functions (e.g. Quality, R&D, Marketing).
Essential Job Duties and Responsibilities
- Participates in audits and inspections of the company and its quality systems.
- Plans and prepares regulatory submission documents for US and OUS regulatory filings under minimal supervision.
- Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements.
- Assist in the development of RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
- Review marketing materials, go-to-market strategies and other commercialization activities as required to ensure continued compliance to established product clearances; lead the development of regulatory strategies for new claims and indications.
- Provide guidance and direction to ensure international product registration/licensing requirements are addressed and met prior to commercial release. Maintain international product registrations.
- Prepares documentation that is complete, accurate, and on time.
- Utilizing detailed, in-depth understanding of regulations, interprets regulations, and provides regulatory guidance to product development teams.
- Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
- Support domestic and international field corrective actions and adverse event reporting.
- Create and update departmental standard operating procedures (SOPs).
- Perform all activities in compliance with the Quality System, ISO 13485, MDR, MHLW, CMDR and all other applicable regulations are met.
Knowledge, Skills and Abilities
- Direct experience with preparing for 510(k), Technical File and Design Dossier.
- Excellent knowledge and experience with global medical device regulatory requirements, design control and product registration.
- Working knowledge of product development process.
- Ability to assess the changes to marketed products and their impact on product registration.
- Ability to identify, research, and analyze technical documentation and governmental regulations
- Excellent oral and written communication skills.
- Experience working in cross-functional product development team.
- Must be able to handle multiple tasks/projects and manage priorities accordingly.
- Effective interpersonal/communication skills.
- Works well under pressure in a dynamic timeline-driven environment.
- Ability to work in a team environment and exert influence without alienating others.
- Ability to work independently with minimal management oversight.
- Under general supervision, works within established guidelines and has flexibility as to method, priority and timing of job duties. This position requires a significant amount of initiative and judgment.
- Extensive experience with MS Word and EXCEL.
- Regulatory Affairs Certification (RAC) preferred.
Education and Experience
- The person responsible for regulatory compliance must possess the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
- Bachelor's Degree in chemistry, scientific or engineering discipline
- 4+ years of work experience in regulatory affairs in medical device, biotech, or pharmaceutical industry
- Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (510(k), IDE, PMA, Technical File, Design Dossier).
- Medical - 100% premium coverage for qualified NWM employees and their dependents
- Vision/Dental - 99% premium coverage for qualified NWM employees and their dependents
- 401(k) with company match
- Life Insurance/AD&D (Basic and Supplemental Term Life)
- Long Term Disability
- Employee Assistance Program - provides assistance and support with issues such as mental health and legal problems
- Generous tuition assistance program (eligibility requirements apply)
- Humanitarian travel program available (eligibility requirements apply)