Combination Products, Medical Device, Quality/Risk Management
4 Year Degree
Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality solutions to medical device companies.? From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post market processes for medical devices. Balancing the art and science of the regulatory and quality landscape has been the hallmark of R&Q’s mission and cemented it’s essence of the "and means more."
The Executive Director of Regulatory & Quality Consulting Services (IVD) is responsible for providing regulatory and quality expertise to both clients and the R&Q Team by researching and developing strategies to ensure compliance with the appropriate regulations while creating overall customer satisfaction. Acts as the R&Q subject matter expert and point of contact for guidance and advice for clients, R&Q Sales Team and Consultants.
Provides proactive guidance to the SVP of Consulting Services to ensure R&Q’s Executive Team is aware of industry trends and risks to the business.
Represents R&Q as a subject matter expert and presenter at industry events and R&Q webinars.
Monitors the competitor landscape and keeps the organization abreast of potential threats and opportunities.
Provides technical guidance in the development of marketing activities.
Provides the leadership and voice of R&Q when guiding clients and employees on complex regulatory and quality situations.
Leads the development of depth of regulatory and quality expertise within R&Q.
Mentors and guides team members to ensure services are performed for clients in an effective and efficient manner.
Offers business balanced solutions by analyzing the style and preferences of individual clients and adapting approach to fit in the client culture, systems and risk tolerance.
Develops and directs the implementation of R&Q’s technical strategy in the evaluation and development of potential new services.
Relies on strong network of industry connections to advance R&Q services.
Supports the sales process by acting as a subject matter expert on sales calls/meetings with prospective clients.
Monitors regulatory intelligence and assesses impact on company and clients; disseminates information as appropriate.
Provides technical leadership and subject matter expertise to one or more of the R&Q CoINs to ensure discussions are aligned with the R&Q regulatory and quality path forward.
Education & Experience Requirements
Bachelor level degree in engineering or a technical field required; advanced degree preferred.
Minimum 20 years’ experience in the IVD industry, required.
Minimum 10-15 years’ experience in acting in a leadership role within an IVD company in regulatory and/or quality.
Previous consulting experience, required.
Expert knowledge of FDA Quality System Regulations, ISO 13485, and EU In Vitro Diagnostics Directive and Regulations (EU IVDR) required.
Prior direct contact with regulatory bodies (FDA, NBs, etc.)
Innovation Management; ability to bring creative ideas of others to market and has good judgment about which ideas/suggestions will benefit the company.
Collaborate with cross-functional teams to produce high quality work and can comfortably switch between collaborative writing and reference platforms (e.g., MS Word, Google docs) to achieve timely deliverables.
Distill large amounts of clinical and scientific data into impactful manuscripts and abstracts.
Ability to motivate teams and simultaneously manage several projects.
Strong Business Acumen, with the ability to think strategically and respond appropriately to customer and employee needs.
High performance orientation, a detail orientation, and strong organization skills.
Excellent interpersonal, communication and influencing skills as well as experience working collaboratively with clients, employees and the medical device industry.
Ability to develop and deliver presentations, as well as professional written and verbal communication and interpersonal skills.
Advanced computer skills including business applications, statistical data analysis and report writing required.
Requires willingness to work a flexible schedule and travel at least 25% of the time.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds. Must follow all safety protocols when visiting client sites including PPE when in a manufacturing and/or laboratory setting.
Being an industry leader in client support is just the beginning for R&Q. Providing a rewarding place to work is rooted deep in the core values of R&Q. From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the “and means more” approach to employment. At R&Q, you are not just another employee, you are a member of the R&Q family. Make your impact today!
We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.
Telecommuting is allowed.
Additional Salary Information: Competitive base and bonus.
Internal Number: 91119
About Regulatory and Quality Solutions LLC
Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality engineering to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post-market processes for medical devices.
Balancing the art and science of the regulatory and quality landscape has been the hallmark of R&Q’s mission and cemented its essence of the and means more.