Location: Little Elm, TX
Department: Regulatory Affairs
Reports To: VP General Counsel & Secretary
Salary: $65,000 – $85,000

SUMMARY

Provides demonstrated knowledge of FDA QSR, ISO 13485, MDD, MDR, Health Canada, and other applicable U.S. and International regulations, including experience auditing these requirements. Previous experience with FDA regulatory submissions and CE marking (510Ks, EU Technical File etc). Able to update technical files and post market surveillance documentation from MDD to MDR for existing products. Responsible for ongoing maintenance of technical files and risk management documentation. Responsible for post-market surveillance and revision of related risk management, as applicable. Provide support for new product development. Maintain documentation in alignment with the latest regulatory requirements.

EDUCATION AND/OR EXPERIENCE

Bachelor of Science degree in a relevant discipline required. Minimum three years of professional experience in regulatory affairs in the medical device industry with a history of successful regulatory submissions in the US, the EU under MDR, and in international markets. Proficiency in Microsoft Word, Microsoft Excel, preferred.

INTELLECTUAL SKILLS

The intellectual skills described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Ability to speak, read and write English.
• Ability to communicate effectively.
• Ability to deal with intricate details.
• Ability to deal with varying degrees of stress induced by urgent business-related requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities include the following. Other duties may be assigned.

• Prepare regulatory strategies and maintain 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.
• Maintain Standards library and oversee the review by appropriate departments of Standard update for compliance analysis of QMS.
• Prepare and maintain domestic and international regulatory registrations, device registrations, listings, certifications, export certificates, and Declarations of Conformity.
• Provide regulatory support during third party audit of the company quality systems and product documentation.
• Submit notifications of significant changes to competent authorities, notified bodies, and authorized reps.
• Submit and maintain registrations, renewals, and all annual filings and fees.
• Work with R&D to create and maintain DHF documents and technical documentation.
• Provide regulatory strategies for product development projects.
• Answer questions from competent authorities, notified bodies, authorized representatives, and distributors and provide documentation as needed.
• Ensure compliance with regulatory and registration requirements in all jurisdictions.
• Update post-market surveillance plans and reports annually and PSURs submissions as required.
• Responsible for understanding and complying with current domestic and international regulatory requirements, including but not limited to FDA, European, Canadian, Australian, and Brazilian requirements.
• Assist with internal and supplier audit programs structured around ISO 13485, the Medical Device

Regulation/EU MDR, and applicable MDSAP regulations including those from the FDA, Health Canada, ANVISA, and the TGA.

• Provide regulatory guidance on design and process validations, product labeling claims, advertising and promotional literature, and clinical studies in compliance with regulations.
• Assists Regulatory Affairs Manager to identify training requirements for new and revised

Documents, special projects, and provides back-up when appropriate.

• Identify and implement methods to comply with responsibilities in a timely fashion.
• Able to meet deadlines, prioritize work, take the initiative to follow-up on outstanding issues, complete assigned tasks, handle multiple tasks, and work independently.
• Comprehensive understanding of the global regulatory environment.
• Ability to get along with others, follow directions, and work well under stressful conditions.
• Highly oriented to customer service and quality improvement.
• Responsible for complying with company policies and procedures, including but not limited to, Quality System Regulations, safety/housekeeping, and Quality Management System.

The intellectual skills described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Ability to speak, read and write English.
• Ability to communicate effectively.
• Ability to deal with intricate details.
• Ability to deal with varying degrees of stress induced by urgent business-related requirements

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.

• While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands, reach, climb stairs, stoop, and bend. The employee must occasionally lift and/or move up to 20 pounds. Intense use of vision is required for document/report inspection/analysis and verification

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• The noise level in the work environment is usually moderate. Lighting is usually fluorescent. Heating/Air Conditioning/Ventilation is usually adequate to accommodate the general office population