SUMMARY

Person responsible for regulatory compliance (EU MDR person responsible), who provides regulatory expertise and guidance for conformance to ISO 13485 and Medical Device Regulation 2017/745 (EU MDR), as well as compliance with applicable regulations such as those defined in the Medical Device Single Audit Program (MDSAP). Act as a subject matter expert to represent the site(s) quality initiatives and compliance objectives in the development of procedures, validations, and quality planning for the facility. Ensures quality systems are established and maintained in compliance with applicable local ordinances, state statutes, and Federal regulations, and other laws. Adheres to national and international regulations by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Ensure the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released.

• Monitors company compliance with ISO standards and applicable regulations.
• Maintains product technical documentation and the EU declaration of conformity up to date.
• Oversees customer complaint handling system including Medical Device Reporting (MDR) and

Adverse Event Reporting

• Oversees Document Control.
• Oversees Change Request Order (CRO) system.
• Oversees Corrective/Preventive Action (CAPA) system.
• Provides project direction, coaching, and monitoring for CAPA teams as required.
• Oversees CAPA system.
• Oversees Temporary Deviations System.
• Oversees Nonconformances System.
• Coordinates 510(k) or PMA submissions to send to the FDA.
• Oversees International registration of products, including coordinating with RTI’s international sponsors regarding MDSAP – related registrations.

• Maintains current registration status with applicable regulatory bodies such as the FDA and Health Canada

• Assists with internal and supplier audit programs structured around ISO 13485, the Medical Device Regulations/EU MDR, and applicable MDSAP regulations including those from the FDA, Health Canada, ANVISA, and the TGA.

• Oversees subcontractor and internal audits and assists with vendor/supplier audits.
• Management Representative for ISO, FDA and other Regulatory Agencies, and third-party audits (FDA, ISO, etc.)
• Acts as point of contact and provides assistance during third party audits (FDA, ISO, etc.)
• Responsible for Post-Market Surveillance and reporting of serious incidents and field safety corrective action obligations.

• Acts as point of contact for the Authorized representative in the Union (EU).
• Serves as Independent Reviewer for product design review and participates as a member of other RTI work groups such as CIT, Kaizen, etc.

• Oversees RTI training system including but not limited to evaluation of training effectiveness and annual QMS training.

• Assists with Quality Plan preparation.
• Schedules and coordinates management review meeting and operations meetings, as well as various online training programs.

• Provides regulatory guidance on design and process validations, product labeling claims, advertising and promotional literature, and clinical studies.

• Provides direct supervision of the assigned team through ongoing leadership and guidance. Supervises day-to-day operations of employees.

• Assists with various projects as assigned by direct supervisor.
• Completes other duties as assigned.
• Identifies deadlines and implements methods to comply with responsibilities in a timely fashion.
• Ability to meet deadlines.
• Ability to get along with others, follow directions, and work well under stressful conditions.
• Responsible for following company policies and procedures, including but not limited to, Quality System Regulations, safety/housekeeping, and Quality Management System.

SUPERVISORY RESPONSIBILITIES

Direct Supervisor of Regulatory Affairs personnel.

EDUCATION and/or EXPERIENCE

College degree, certificate or other evidence of formal qualification awarded on completion of university degree, or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline. At least one year of professional experience in regulatory affairs, or in quality management systems relating to medical devices, or four years of professional experience in regulatory affairs or quality management systems relating to medical devices. Five or more years’ experience in an ISO/FDA manufacturing environment… CQA or RAC are preferred. Experience in computer/database software applications, preferably M/S Word, M/S Excel, M/S Access, and Audit Master 3.

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.
• Excellent customer relations and organizational skills.
• Excellent reporting, writing and presentation skills.
• Ability to communicate effectively with production and quality staff as well as all levels of management.
• Ability to multi-task.
• Ability to deal with varying degrees of stress induced by urgent business-related requirements.

PHYSICAL DEMANDS

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, stoop and bend, climb stairs.  The employee must occasionally lift and/or move up to 20 pounds.  Intense use of vision is required for document/report inspection/analysis and observation of  products and measuring equipment. Employee must be able and willing to travel, (travel is minimal).

WORK ENVIRONMENT

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 adjusted to accommodate production or laboratory environmental requirements. Employee may be subject to outside weather conditions when traveling on company business.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.