Sr. Regulatory Compliance Engineer

Sunrise Medical (US) LLC•Mount Juliet, TN

47d

About The Position

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.

Requirements

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.
Analytical Thinking – Approaching a problem by using a logical, systematic, sequential approach.
Building Collaborative Relationships – Developing and maintaining partnerships with others.
Developing Others – Delegating responsibility and coaching others to develop their capabilities.
Diagnostic Information Gathering – Identifying the information needed to clarify a situation, seeking that information from appropriate sources, and using skillful questioning to draw out the information.
Forward Thinking – Anticipating the implications and consequences of situations and taking appropriate action to be prepared for possible contingencies.
Fostering Teamwork – As a team member, the ability and desire to work cooperatively with others on a team; as a team leader, interest, skill, and success in getting groups to learn to work together cooperatively.
Influence Skill – Gaining others’ support for ideas, proposals, projects, and solutions.
Initiative – Identifying what needs to be done and doing it before being asked to or required by the situation.
Oral Communications – Expressing oneself clearly in conversations and interactions with others.
Personal Credibility – Demonstrated concern that one be perceived as responsible, reliable and trustworthy.
Persuasive Communication – Planning and delivering oral and written communications that are impactful and persuasive with their intended audiences.
Providing Motivational Support – Enhancing others’ commitment to their work.
Results Orientation – Focusing on the desired end result of one’s own or one’s unit’s work; setting challenging goals, focusing effort on the goals, and meeting or exceeding them.
Self Confidence – Faith in one’s own ideas and ability to be successful; taking an independent position in the face of opposition.
Written Communication – Expressing oneself clearly in business writing.
Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
Fluency of Ideas — The ability to come up with a number of ideas about a topic.
Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
Lifting/ Carry Weight - Must frequently move and lift up to 10 lbs. and occasionally lift and/or move up to 40 lbs.
Mathematical Reasoning — The ability to choose the right mathematical methods or formulas to solve a problem.
Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
Oral Expression — The ability to communicate information and ideas in speaking so others will understand.
Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
Selective Attention — The ability to concentrate on a task over a period of time without being distracted.
Speech Clarity — The ability to speak clearly so others can understand you.
Speech Recognition — The ability to identify and understand the speech of another person.
Written Comprehension — The ability to read and understand information and ideas presented in writing.
Written Expression — The ability to communicate information and ideas in writing so others will understand.

Nice To Haves

Certified Regulatory Specialist and/or Quality Engineer and/or Six Sigma Black Belt Certification preferred.

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.