Quickie Wheelchairs - Manual and Power · 2 months ago
Sr. Regulatory Compliance Engineer
Mt. Juliet, TN, USA
Full-time
Onsite
Mid, Senior Level
4+ years expQuickie Wheelchairs, a part of Sunrise Medical, is dedicated to enhancing lives through innovative mobility solutions. The Sr. Regulatory Compliance Engineer will work closely with global quality and regulatory teams to ensure compliance with applicable regulations and manage documentation for medical devices.
Medical Device
Responsibilities
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 points
Support department initiatives for maintaining current regulatory knowledge and communications
Supports new product development activities, participating in project meetings, design reviews, risk management, and other activities as required by the Design Control Process
Reviews Design History Files for accuracy and compliance to internal and FDA requirements
Regularly perform a verification of the marketing documentation and the content of websites in regards of regulatory correctness
Enter necessary data into the electronic databases, including the complaint management system
Aid in liability claim investigation and document collection
Participate in FDA/External/Internal Audits or inspections, as needed. Provides analysis of internal Quality issues and provides recommendations for improvements
Participates on Build-4-Me Product Development and Manufacturing team to assure that all quality and regulatory issues are addressed for customer requested modification
Request Certificate of Free Sales for export
Support the international sales team for customer demand and tender application
Mentors Quality Engineers and technical staff
Leads continuous improvement projects and identify opportunities for improvement in Quality and Manufacturing
Provides Regulatory review and authorization for documentation changes to engineering prints, Quality Plans, manufacturing work instructions, process sheets, inspection plans, labeling, etc. Provides Regulatory review for product design changes, as needed
Works closely with Manufacturing and Manufacturing Engineering and product engineering in determining process capability and process validation, as needed
Support the creation of Product Quality and Inspection Plans to manage in-process product evaluation points, levels and criteria, as needed
Provides Material Review Board (MRB) disposition for nonconforming product, as needed
Conducts or participates in supplier audit, qualification and certification activities as required
Other special projects/assignments as designated by management
Qualification
Required
Bachelor of Science in an engineering discipline or equivalent experience. Mechanical, Manufacturing, Process or Quality Engineering Degree a plus
Four plus years of relevant experience in a medical device quality/regulatory environment (Class 1 or 2)
Knowledge of ISO 13485, 21 CFR 603, 21 CFR 806, 21 CFR 820, ISO 14971, SOR/98-282, and EU MDR preferred
Strong working knowledge of computer database systems, Microsoft applications, PC, and various software programs required
Strong aptitude for problem solving, root cause analyses, and statistical analyses. Process/product validation experience
Experience with Quality Risk Assessment tools such as HARMs, FMEA, MRB, CAPA, required
Capable to present data (presentations) to management teams and train co-workers as needed
Must have ability to properly interpret Engineering drawings and clearly present that information to others
Ability to interface with a variety of associates with exceptional communication skills
Must have ability to present data clearly and concisely
Ability to travel to other Sunrise facilities to support quality audits and issues
Preferred
Knowledge of ISO 13485, 21 CFR 603, 21 CFR 806, 21 CFR 820, ISO 14971, SOR/98-282, and EU MDR preferred
Certified Regulatory Specialist and/or Quality Engineer and/or Six Sigma Black Belt Certification preferred
Benefits
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
Company
Quickie Wheelchairs - Manual and Power
For over 25 years, Quickie has listened, researched, tested and delivered.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase