Sharon brings over 19 years of rich expertise in Quality and Regulatory affairs within the medical device industry, including more than 9 years as a consultant. As a seasoned professional, Sharon has a proven track record in setting up comprehensive Quality Management Systems and guiding companies from the initial stages of product development through to their regulatory submissions.
At the heart of Sharon's approach is a strong belief in the critical role of quality in producing safe and effective medical devices. She achieves this by fostering organizational excellence, offering strategic guidance, and inspiring team involvement. Her leadership style encourages employees to share their insights and ideas, blending their unique experiences and knowledge to create efficient processes that not only meet but exceed regulatory standards.
Sharon's expertise as a Certified Manager of Quality and Organizational Excellence (CMQ/OE) and Lead Auditor is particularly noteworthy. She possesses a deep understanding of the diverse regulations and standards in the dynamic field of medical devices. Her ability to identify gaps through internal or supplier audits is invaluable, and she actively supports leadership in corrective actions and remediations to their quality management systems.
In her professional capacity, Sharon leads QA/RA teams with dedication, provides training and mentorship to the staff, and collaborates across departments to ensure the design and manufacture of safe and effective medical devices. Her responsibilities also include overseeing the preparation of technical documents, ensuring they meet the necessary standards, creating regulatory documents and supporting daily operations aligned with the organization's goals.
Sharon's focus is always on forging efficient and results-oriented relationships with her clients. She works closely with each client to develop tailored action plans that address their specific organizational needs.
Sharon Resnick, QA/RA Expert
We have open dialogues, a positive attitude and we team up to success with other great partners, leveraging each other's knowledge, competence and expertise to provide our comprehensive services as promised.
With our hands-on practical experience, we deliver quality services to our clients, focusing on results and seeing things through.
We are committed to honesty, trust, and transparency and we do the right thing even when no one is watching.
We take our work seriously and strive to deliver exceptional results for every project so that you can get safe medical devices to your patients and users.
We take an outside perspective to overcome obstacles and find solutions together with our clients.
We love what we do, and we do it with love.
We constantly learn, improve and develop, staying on the cutting edge to provide a service that’s anything but basic.
Sharon and I worked together for a decade. Sharon is an extremely dedicated, hardworking, and devoted professional and she is highly appreciated by peers, partners, and customers. Sharon is a certified, qualified, and very experienced quality and regulatory expert.
She served in multiple roles and company structures starting from a medical startup growing into international corporate arena following our company’s acquisition and finally as an independent consultant to many firms. She is highly appreciated and recommended by all who worked with her over the years (D.D)
Sharon works with us on CE MARK submissim. Sharon is very professional. She assists us in building and managing a very tight submission, including providing document templates, guiding us through all the neede standards and directives.
Sharon is always available for quick answers as well as thorough and tight guidance and support (V.K)
Highly professional QA/RA specialist with years of expiriance in FDA and NB applications. It is always a pleasure to work with Sharon. She is a treasure for every company (A.N)
Sharon is a professional quality and regulatory manager and consultant with vast knowledge in medical device, quality management systems, regulatory submissions and other aspects of the job. Sharon is a true leader, a great team member and excellent communicator. Over the past few years I've had the pleasurer of working with Sharon on a number of projects and I highly recommend her for any QA/RA project or role (I.H)
I'm so happy I have you on my side. You make things so simple and easy, now I finally understood how this process works
(M.Y)
I wanted to write to you personally - thank you so much for the support and help lately. Your availability and professionalism should not be taken for granted and you have given me so much beyond my expectations. I totally feel like you upgraded me in a few levels in such a short period of time that we worked together. (M.Y)
Sharon is one of the best all-around QA/RA Consultants that I have worked with. She understands the industry, the regulations, and the balance between business needs and compliance. She handles audits exceptionally well and effectively manages her projects. She is able to navigate in complex, matrixed organization. Sharon is a strong asset to any organization.
(A.L)
I can personally attest to her ability to work with clients and do high quality and imaginative work. (J.J.C)
Sharon played a crucial role in assisting with various QA/RA challenges. Her expertise in navigating complex regulatory requirements, coupled with a deep understanding of quality management, significantly contributed to our success in achieving and maintaining compliance.
(F.R)
Sharon is a high-level specialist, a reliable partner with excellent communication skills. Every project she takes on is guaranteed to succeed. I recommend her without reservation.
(V.M)
Sharon was my colleague in Physio-Logic, A Medical Devices consulting house, for 4 years. Sharon is very versed with FDA and CE submissions to Notified Bodies, Internal Audits both in Israel and USA, creating Technical Files for Class III devices and QMS.
Sharon is a diligent professional and fully dedicated to her work. Her knowledge is outstanding in a way that often colleagues approached her to ask for advice and opinion about complicated issues.
Sharon used to complete her tasks with a short time and gained praise from the customers. Sharon is considered as excellent consultant among the Medical Devices consultants in Israel.
(I.G)
I am delighted to recommend Sharon as an exceptional consultant in QA/RA. Having worked closely with her, I’ve witnessed firsthand Sharon’s deep expertise in navigating regulatory requirements and ensuring seamless compliance with global standards. Her guidance was instrumental in achieving critical quality and regulatory milestones.
In addition to her technical expertise, Sharon shines in her collaborative approach and unwavering dedication to quality. She consistently brings a personal commitment to excellence, going above and beyond to ensure success. Sharon is not only a strategic thinker but also a genuine pleasure to work with, making her an invaluable asset to any team.
(I.M)