Senior Regulatory Assurance & Quality Specialist
Regulatory & Quality Solutions LLC 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 augments existing staff or lead the project for the customer with a heavy involvement in both Class I and Class II medical devices. We are adding a Senior Regulatory Assurance & Quality Specialist to our team and we would like to talk with you.
Our teams engage with clients from early stage medical device product concepts 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 at all professional levels..
The Senior Regulatory Assurance & Quality Specialist opening is a key member of the Quality & Regulatory team who is responsible for providing, under limited direct supervision, regulatory and quality solutions to assist clients with the introduction, advancement and/or maintenance of their market positions or growth in their markets. This particular position will have 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 Senior Regulatory Assurance & Quality specialist.
Scope & Responsibilities:
•Prepares 510(k) submissions to be reviewed and submitted by senior level RAQA personnel.
•Prepares Design Dossiers and Tech Files for EU.
•Assists in writing/reviewing product labeling.
•Assists with complex world-wide regulatory strategies.
•Assists with and completes, with supervision, regulatory assessments in support of new product initiatives and product line extensions.
•Assists with regulatory submissions for other key areas of the world (Asia/Pacific, the Americas).
•Prepares and files domestic/foreign registrations, listings, applications .
•Provides regulatory intelligence information to the organization.
•Aides in definition of supplier quality specifications, sampling plans, and supplier qualification.
•Aids in Writing/Reviewing Verification & Validation Test Protocols and Reports.
•Assists with Usability (IEC 62366) and Safety Risk Management Activities (ISO 14971).
•Assists with the design verification and design validation plans for products based on performance specifications and risk analysis.
•Assists and conducts Quality & Regulatory Training For Clients.
•Assists and develops Quality Systems per ISO13485:2003.
•Assures Audit Finding Recommendation Implementation.
•Assists and completes supplier audits to ISO 13485:2003.
•Assigns/leads and/or performs investigative tasks to determine root cause and resolution of identified quality issues.
•Works closely with manufacturing and engineering, and support departments to assist in complaint analysis and document investigations applying quality knowledge with assurance standards.
As a customer resource, this is an intensive project management role working closely with customers on their product-to-market initiatives. As a Senior Regulatory Assurance & Quality Specialist with our company, you need to be proficient will all aspects of quality and regulatory requirements, have superior project management skills, and know how to effectively interact with customers who are the existence of our business.
Senior Regulatory Assurance & Quality Specialist Qualifications:
•BS degree in a technical discipline with 2-10 years’ experience in a medical device / regulated industry. CQA / CQE, CLA, RAC preferred.
•Demonstrated Experience with quality standard ISO 13485, ISO 14971, 21 CFR820, IEC 62366 preferred.
•Previous experience in preparing 510(k) / PMA, design dossiers and technical files submission for disposables, software, and electro-mechanical devices highly preferred.
•Technical comprehension of appropriate FDA medical device regulations, safety standards and regulatory compliance guidelines.
•Previous quality engineering experience and demonstrated use of quality tools and methodologies preferred.
•Experience with worldwide regulatory registrations preferred.
•Experience with development and creation of entire ISO 13485 compliant quality systems would be considered a plus.
•Demonstrated customer support (internal and external), and working with all levels of an organization supporting business relationship and business opportunities.
•Successful track record of managing multiple tasks and performs with accuracy and a high attention to detail.
•Strong written, oral and interpersonal skills to be able to effectively interface with team members and our clients.
•Plans, organizes, and prioritizes own work routine to meet established schedule of customer projects and support the activities of regulatory assurance and quality standards for our customers.
•Demonstrated skills in WORD, EXCEL, and PowerPoint.
As 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 from home solutions based on your needs.
Let us know how YOU can contribute to our team!