As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.
Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.
Senior Regulatory Affairs Specialist
Regulatory Affairs Manager
Allen, TX 75002
Provides regulatory guidance to product development teams on strategic planning to support optimal timelines for product launches. Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and Technical Files. Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. Helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. The role is a Subject Matter Expert in the development of best practices for Regulatory Affairs process and stays up to date on regulatory intelligence to better serve the organization.
- Bachelor of Science degree in a relevant discipline required.
- Minimum 5 years of experience in medical device Regulatory Affairs with RAC certification or 10 years of experience w/o certification.
- Demonstrated knowledge of FDA QSR, ISO13485, MDD, MDR, Health Canada, and other applicable U.S. and International regulations, including experience auditing these requirements.
- Knowledge of Japanese, Australian, and Brazilian requirements preferred.
- Demonstrated knowledge of ISO 14971 and ISO 10993.
- Experience with preparing and filing reportable events (MDRs) and Vigilance Reports.
- Previous experience with FDA regulatory submissions and CE marking.
- Experience interacting with regulatory bodies, such as the FDA and Notified Body.
- Experience with the Biocompatibility testing process preferred.
- Excellent prioritizing, organizational, and interpersonal skills. Ability to handle multiple projects simultaneously.
- Ability to review and provide critical feedback on design documentation.
- Excellent writing and communication skills. The individual should be detail-oriented and have good deductive and problem solving skills. Due to the requirements of a quality assurance environment, a certain degree of initiative and good mechanical aptitude would be advantageous.
- ASQ certification as a Certified Quality Auditor (CQA) a plus.
- Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices.
- Reviews and summarizes post-market surveillance feedback, such as customer feedback, adverse event reporting, customer surveys, trade shows, and publications.
- Evaluates and documents all alleged reportable events and field action reviews/assessments. Prepares and submits all MDRs and associated documentation to the FDA and adverse event reports to other countries within the required timeframes. Follows-up, as required, for failure investigations associated with reportable events. Interacts with the FDA and other regulatory authorities on all MDR or reportable events.
- Maintains and prepares device registrations, listings, certifications, export certificates, and Declarations of Conformity.
- Responsible for understanding and complying with current domestic and international regulatory requirements, including but not limited to FDA, European, Canadian, Australian, Japanese, and Brazilian requirements.
- Acts as a Regulatory Affairs representative on core product development teams. Communicates regulatory requirements and impact of regulations to the development teams. Reviews design history files to ensure all regulatory requirements are being met.
- Reviews and provides regulatory authorization for labeling, marketing literature, and protocols/ reports for compliance with regulatory requirements.
- Evaluates, investigates, documents and communicates with both the FDA and/or other regulatory authorities on all product recalls. Writes recall communications to the field and customers. Documents and reconciles product inventory associated with recall. Follows up with corrective action associated with recall issues.
- Provides oversight of third party testing (UL, EMC, biocompatibility, sterilization assurance) as required.
- Supports an effective internal audit program. Reviews processes for compliance to appropriate regulations and internal procedures.
- Provides support for external audits conducted by Quest customers, regulatory authorities, and Notified Bodies.
Notables / Benefits:
- Summer hours
- Mid-size company with great company culture that is well diverse
- Have a voice in the company
- Average tenure for employee population is 7+ years
- 401k with employee matching available
- Paid vacation and other excellent benefits
An Equal Opportunity Employer