Medical Device, Quality/Risk Management, Regulatory Compliance, Submission & Registration
4 Year Degree
Qfix provides state-of-the-art patient positioning and immobilization devices to optimize patient outcomes. We are a dynamic privately held, rapidly growing innovator, manufacturer and marketer of advanced technology for patient positioning and immobilization devices in the radiation therapy market.
The Regulatory Affairs Specialist provides global support for Class I and Class II medical devices; is responsible for activities that lead to and maintain regulatory approval/clearance of these devices; and assesses the regulatory implications of changes to these devices.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provide regulatory support on product development teams through the product life cycle on product project teams
• Assists with regulatory assessments for manufacturing, design changes, and validation activities
• Provide the appropriate information to support international product registrations.
• Identify submission requirements, review acceptability of documents for submissions, and prepare dossiers to support product registrations for international markets
• Assist with regulatory registrations by working with regulatory bodies.
• Identify guidance documents, international standards and consensus standards, and risks and assist product development teams with their interpretation.
• Review and approve product labeling, claims, training materials and advertising/promotional materials to ensure valid label claims are consistent with US and international rules and regulations.
• Supports product blocking lists to ensure valid international regulatory clearances, sales. Assess commerce implications.
• Assist in negotiations with the FDA or other regulatory agencies.
Knowledge of Global Medical Device Regulations
Must ability to interpret regulatory standards and guidance.
Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
Must have good interpersonal skills and the ability to interface with all levels of the organization and outside customers.
Must have excellent verbal and written communication skills
Must be able to lead meetings and clearly present ideas to employees and other stakeholders.
Must have strong problem solving and analytical skills
Additional Salary Information: Compensation is dependent on Experience
Internal Number: 101
Qfix is an innovative medical device company focused on discovering, developing and commercializing technology-driven solutions for radiotherapy patient positioning. Our focus is to foster a deep engagement with medical professionals to design and innovate patient positioning solutions. We make it our business to listen closely to the needs of medical professionals and together we advance precise positioning solutions for cancer treatment.
As the inventors of the most recognized brand of low temperature thermoplastic, Aquaplast RT™, we have continued to innovate with the most rigid thermoplastics on the market, Fibreplast®. Qfix is known for our superior thermoplastics and revolutionary positioning devices. We have a wide portfolio to fit all patient positioning needs and treatment options. The kVue™ IGRT couch top supports an array of interchangeable inserts for multiple simulation and treatment solutions. No other product offers a more complete and advanced system for both kV imaging and MV treatment. We specialize in devices that offer a unique combination of rigidity and ultra-low attenuation. We also have a full offering of MR compatible devices for simulation and treatme...nt.
Our goal is to provide the best patient positioning systems for radiation therapy for unsurpassed outcomes. With over 40 years of experience patient comfort and outcomes is the utmost importance in all of our products.