Manager, Regulatory & Quality Assurance Job in Cleveland, Ohio US
Manager, Regulatory Quality Assurance
Regulatory Quality Solutions LLC
www.raqasolutions.com provides full-service regulatory affairs and quality assurance expertise to medical device organizations. We navigate the complex regulatory landscape and determine the most efficient paths to a safe and effective product, cleared for U.S. and international marketing. This is accomplished through results-driven, experienced team members providing our clients with on-site leadership and support in all areas of regulatory affairs and quality assurance.
Regulatory Quality Solutions LLC specializes in servicing client who have Class I and Class II medical devices. We take great pride in our relationships. We care for our client companies as if they were our own…their success is our success.
We are adding a Manager of Regulatory Assurance Quality to our Cleveland team and we would like to talk with you.
Voted in the top 25 Best Places to work in Western Pennsylvania, our company culture supports collaborative input from our entire project team. We engage best practices supporting our customer initiatives of producing safe and effective medical device products worldwide. We work closely with large scale medical device manufacturers and small to medium start-up operations by helping each be successful in medical device product launch. Our teams engage with clients from early stage product concept and development pre-launch projects through post launch projects and support including; product development and testing, quality system development and training, FDA 510k submissions, manufacturing worldwide registrations, device listings, product quality, quality system auditing, risk management process development, and field corrections to name a few of the items we support. As we continue to grow, we are always looking for professionals with great medical device talent.
Our current Manager, Regulatory Quality Assurance opening is a key member of the Cleveland Quality Regulatory team and responsible for providing direct supervision to RQS associates who assist clients with the introduction, advancement and/or maintenance of their market positions or growth in their markets. This particular position has the unique opportunity of working with both large scale medical device manufacturers as well as small to medium start up manufacturers. The following is a list of possible day to day responsibilities which are dependent of course on the client needs and define the
Manager, Regulatory Quality Assurance Scope Responsibilities:
Operations
- Manage Cleveland operations to insure production efficiency, quality, service, and cost-effective management of resources.
- Manage Cleveland team members to ensure services are performed for clients in an effective and efficient manner.
- Develops and directs the implementation of the strategic business and/or operational plans, projects, programs, and systems.
Customer Relationship Management
1. Leads the customer interface with the client providing overarching customer contact and leadership and ensuring 100% satisfaction.
2. Ensures all projects are on schedule and hitting cost targets, profit margin, and in compliance.
3. Reviews and approves customer invoices and ensures projects are on schedule and on target cost-wise.
Regulatory
1. Leads RQS on new product development teams by preparing and submitting Design Dossiers and Tech Files for EU. Writing/reviewing product labeling and Reviews and approves marketing literature.
2. Leads and develops complex world-wide regulatory strategies and regulatory submissions for other key areas of the world (Asia/Pacific, the Americas).
3. Leads and develops regulatory assessments and strategies in support of new product initiatives and product line extensions, Ensures compliance with all applicable regulations and standards, Monitors changes to domestic and international regulations and standards assess impact on company / clients.
Quality Compliance
1. Conducts client internal and external audits to QSR/ISO13485/MDD requirements and Assist with product recalls.
2. Leads the development of corporate policies and procedures and Develops training presentations.
3. Assists in government agency audits and respond to audit findings and Advises customers with regard to compliance to ISO13485:2003 with a Business Balanced Approach. Leads and completes supplier audits to ISO 13485-2003.
4. Leads and completes RQS Internal Company Quality Audits, Assists and conducts Quality Regulatory Training for Clients. Assists and develops Quality Systems per ISO13485:2003. Assists and develops Quality System Plans. Oversees and Closes Quality Audit Findings.
5. Assists with Acquisition Integration activities. Assists with completion of Due Diligence for Venture Capital.
6. Plans Quality Systems implementation ensures all recommendations to clients are approved by RQS Management as per company policy. Ensures all recommendations and deliverables are approved by the client as per company policy.
7. Monitors the competitive landscape and advice organization on actions to be taken with regard to opportunities or threats.
Product Quality
1. Leads definition of supplier quality specifications and product quality documentation, sampling plans, and supplier qualification; ensure conformance to medical device regulation. As needed, leads the transfer of product lines from one manufacturing facility to another.
2. Leads the development of Master Process validation plans as well as leads the completion of process validations and Leads the development of manufacturing procedures and inspection plans to ensure product conforms to specification
3. Leads the development of the product quality documentation in manufacturing required to ensure conformance to medical device regulation.
Project Leadership
1. Lead customer projects as defined in the RQS Project Management Procedure.
2. Ensures the projects are well planned, communicated to the client and Customer Relationship Manager, and the internal team understands the project, the scope of the project, and executes effectively.
3. Project lead is responsible for scheduling, managing the project to closer, hitting schedules and target profit margins.
Marketing/Client Service
1. Logs complaints and refers complaints to appropriate staff for resolution. Informs and reports findings to the President.
2. Conveys a sense of confidence and assurance to clients when they call with questions or concerns.
3. Participates in identifying and implementing improvements to client service.
Regulatory Quality Solutions LLC
Let us know how YOU can contribute to our team!
RQS, LLC is an equal opportunity employer and a family centric organization. We offer an unmatched fringe benefit program to include health, dental, wellness care, training / education, and remote work solutions.