Principal Regulatory Affairs Specialist
Company: Orange County Regulatory Affairs Discussion Group
Location: Rancho Cucamonga
Posted on: October 18, 2024
Job Description:
Application link: JOB SUMMARY:The Principal Regulatory Affairs
Specialist is responsible for developing and authoring regulatory
submissions (i.e., Q-Submissions, 510(k), IDE, and PMAs) and
providing critical input on cross-functional project teams. The
Principal Regulatory Affairs Specialist will develop and implement
regulatory strategies to obtain timely approvals from regulatory
authorities worldwide. This is accomplished by ensuring submissions
are accurately prepared and comply with global regulations.The
Principal Regulatory Affairs Specialist will understand the
regulations governing medical devices and will be responsible for
assessing changes to medical devices and products or processes to
determine the regulatory implications and performing regulatory
activities to support implementing the device changes. Develops and
maintains solid working relationships with other organizational
functions (e.g., Quality Assurance, R&D, Sustaining
Engineering, and Marketing) and will participate in new product
development meetings and activities and support international and
domestic registrations, including Technical Files.ESSENTIAL JOB
DUTIES AND RESPONSIBILITIES:
- Providing regulatory guidance to cross-functional partners,
developing global regulatory strategies for new and modified
medical devices.
- Assist in the development of the regulatory strategies for new
products and design changes - ensuring regulatory requirements for
target markets are met.
- Preparing and submitting regulatory submission documents for US
and OUS regulatory filings under minimal supervision for the EU and
supporting outside of US (OUS) geographies.
- Represent Regulatory Affairs on assigned project teams through
all phases of product development and communicate regulatory
requirements.
- Prepare Technical Files /Design Dossier, Change Notifications,
and Submissions (e.g. Documentary Audits under MDD/ MDR).
- Provide guidance and direction to ensure international product
registration/licensing requirements are addressed and met before
commercial release to maintain international product
registrations.
- Responsible for ensuring compliance with all relevant quality
system regulations, including EU MDR Regulation, ISO 13485:2016, 21
CFR Part 820, and the Regulations applicable for MDSAP
certification.
- Prepare 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 requirements,
product claims, and target markets early in the product development
lifecycle.
- Participates in audits and inspections of the company and its
quality systems.
- Review marketing materials, go-to-market strategies, and other
commercialization activities as required to ensure continued
compliance with established product clearances; lead the
development of the regulatory strategy for new claims and
indications.
- 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 to
ensure all requirements are met.
- All other duties as assigned.KNOWLEDGE, SKILLS AND ABILITIES:
- Direct experience with preparing premarket documents such as
510(k), IDE, PMA, Technical File, and Design Dossiers.
- Direct experience with preparing Pre-Submission and interfacing
with FDA personnel.
- 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, analyze technical documentation,
and interpret governmental regulations
- Excellent oral and written communication skills.
- Serve as regulatory liaison and work in cross-functional
product development team.
- Capable of handling multiple tasks/projects and managing
priorities accordingly.
- 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 the flexibility to manage, and prioritize 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:
- 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 submissions for medical
devices (Q-Submission, 510(k), IDE, PMA, Technical File, Design
Dossier).PHYSICAL REQUIREMENTS:
- Must be able to remain in a stationary position for at least
50% of the time, including sitting at a desk and working on a
computer.
- Occasionally move about inside the office and travel to and
from office buildings. This may include but is not limited to,
bending and walking.
- Must be able to operate a computer and other office
productivity machinery, such as a computer printer, a computer
keyboard, a calculator, etc.
- Occasionally lift up to 15 pounds. This may be performed with
reasonable accommodation.
- View and type on computer screens for long periods.This
description reflects management's assignment of essential
functions; it does not proscribe or restrict the tasks that may be
assigned.
#J-18808-Ljbffr
Keywords: Orange County Regulatory Affairs Discussion Group , Upland , Principal Regulatory Affairs Specialist, Other , Rancho Cucamonga, California
Didn't find what you're looking for? Search again!
Loading more jobs...