Sr. Regulatory Compliance Engineer

Job Details

Level
:
Experienced

Job Location
:
Mt Juliet - Mt. Juliet, TN 37122

Position Type
:
Full Time

Education Level
: 4 Year Degree

Job Category
: QA - Quality Control

Do you have experience in quality & regulatory and looking for the right employment opportunity that not only has a great compensation package that is based on skills and experience but whose work is also meaningful? Join our Quality & Regulatory Team!

Who we are

Sunrise Medical is committed to improving people's lives by providing innovative, high-quality mobility products and services that exceed customer expectations. Sunrise Medical is a world leader in the development, design, manufacture, and distribution of manual and powered wheelchairs, mobility scooters, and both standard and made‑to‑order seating and positioning systems.

What we offer

• Excellent health benefits plans, which includes FSA and HSA options
• Life insurance
• 401(k) with company match
• Generous vacation, paid sick time‑off and paid holidays
• Employee Assistance Program
• Employee Resource Groups
• Wellness programs and benefits
• Education Reimbursement Program

Job Summary

• Work with the Global Quality and Regulatory teams to ensure all documentation is appropriate, complete and in compliance with all applicable regulations; prepare responses to the competent authority requests.
• Manage, and establish / maintain compliance with FDA And Health Canada QSRs and other global regulation as applicable. This includes, but is not limited to, timely registration of establishments and listing of devices for all facilities and outsource partners, development, and submission of regulatory requirements for product projects, submission of premarket notifications in accordance with FDA and foreign regulatory body requirements, license renewals, initial and annual product reports, etc.
• In charge of monitoring the regulatory requirements and inform the respective stakeholders for the initiation of preventive actions
• Coordinate activities with appropriate departments (e.g., Product Management, R&D, Quality, Customer Service, etc.) to ensure conformity to applicable regulatory requirements in North America.
• Develops and maintains procedures to document and clarify Quality/Regulatory processes.
• Generates and contributes to fulfilling requirements of Postmarket Surveillance (PMS) obligations in conformance with SOR/98-282, 21 CFR 820.198, 21 CFR 822, and FDA Guidance: "Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act." Also ensures supplements are filed in a timely manner with appropriate follow‑up and complete and accurate reporting.
• Contact customers / end users as required for additional follow‑up on complaints / adverse events, as needed.
• Generate and file MDRs (Medical Device Reports – U.S.) or MPRs (Mandatory Problem Reports – Canada, in cooperation with Canadian head of regulatory) on time, as needed.
• Manage Recall/FSCA and track the status through completion.
• Lead effort for daily review of reported complaints and/or returns for trending and identification of potential regulatory reporting and corrective/preventive actions.
• Lead and coordinate Document Control activities to support the Quality Management System.
• Lead risk management activities in cooperation with product development teams on product enhancement projects and new product development initiatives for use‑case scenarios.
• Leads product failure investigations and risk analysis activities as required.
• Coordinate with appropriate departments the gathering and reviewing of data regarding market observations on Sunrise products as well as competitor products (similar products) for evaluating failure trends in product types.
• Evaluate proposed corrections and/or removals. Coordinate with Remedial Action Board and Global Regulatory Board for response to corrections and/or corrective actions. Participate in activities as determined by RAB and GRB.
• Administers the Corrective Action Preventive Action (CAPA) system by working closely with suppliers and internal process owners to ensure appropriate corrective and preventive action is implemented.
• Establish methods for data analysis and trending, along with appropriate trigger…