ESSENTIAL FUNCTIONS PERFORMED
Primary responsibilities are to ensure regulatory compliance for assigned product lines as Merit evolves. Other responsibilities may include coordinating recalls, identifying relevant standards and guidance documents that affect Merit's business and products, assisting with FDA facility inspections, Notified Body audits, conducting internal audits when directed and making MDR, MPR or vigilance report recommendations.
* Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
* Prepares regulatory submissions to the FDA, the Notified Body, HealthCanada, and other regulatory authorities.
* Participates on various teams to define regulatory requirements of U.S. and international submissions or regulatory rationales.
* Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
* Prepares IDEs and PMAs and assists with clinical trials when required.
* Interacts with various levels of management, government agencies, consultants, clinicians, and companies.
* Analyzes and makes recommendations regarding complaints received by Merit Medical and whether they are MDR, MPR or vigilance reportable; participates in complaint related meetings.
* Develops, maintains and analyzes department systems and provides training when needed.
* Remains current on developing regulations and revises procedures as necessary.
* Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed.
* Works closely with global regulatory team to share experiences, assist with international registrations, and advance common knowledge. Leads presentations, training, and discussions.
* Assists with supervision of department staff, as directed.
* Performs other related duties and tasks, as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
* Lifting -- Not to exceed 50 lbs -- local practice may apply * Writing * Sitting * Standing * Bending * Vision * Color perception * Depth perception * Reading * Field of vision/peripheral * Fine motor skills
SUMMARY OF MINIMUM QUALIFICATIONS
* Education and experience equivalent to a Bachelor's Degree, preferably in the biological, physical, engineering or material science disciplines, and six years of experience in medical device regulations.
* Demonstrated experience authoring US 510(k) submissions, EU Technical Files/Design Dossiers, and Canadian Medical Device License Applications.
* Demonstrated knowledge of US FDA regulations, the Medical Devices Directive (93/42/EEC, as amended)/MDR (2017/745), Canadian Medical Device Regulations, and various quality system standards/regulations/laws, including but not limited to 21 CFR 820, ISO 13485, ISO 10993, etc.
* Supervisory or mentorship skills are preferred.
* Self-motivated, self-directing, strong attention to detail and excellent time management skills.
* Strong interpersonal skills and the ability to communicate well -- verbally and in writing.
* Demonstrated computer skills including spreadsheets, word processing, e-mail, database, internet research and other applicable software programs.
* Regulatory submission/rationale preparation * Medical device and vigilance reporting * Computer skills/internet research * Interpersonal/communication skills * Regulatory system development/training