Position Summary

The Senior Regulatory Specialist position supports the management of Medacta USA’s regulatory strategy.  This includes coordination of necessary product priorities, development of department processes and procedures, and support for the Medacta USA operations, R&D, marketing, and sales teams.

A.

Knowledge:

1

Minimum Educational Requirements

Bachelor’s Degree in Life Science or Engineering field or an associate’s degree in conjunction with 3+ years’ experience in the medical device field is required.   

2

Minimum Experience Requirements

3 - 5 years’ experience in the Medical Device industry.

3

Minimum Skill Requirements

Strong interpersonal and communication skills.  Ability to communicate effectively both verbally and in writing.  Highly organized and detail oriented. Ability to convey complex information in understandable terms to individuals at all educational levels.  Ability to analyze and solve problems.  Ability to handle multiple tasks concurrently. Excellent time management skills.  Demonstrated knowledge of FDA medical device quality system regulations.  Experience with orthopedic and / or spine 510(k) submissions.  RAC certification is a plus.

4

Equipment or Machines Used

PC, Microsoft Office software suite, general office equipment.

B.       Principal Duties

·        Coordinates the development of 510(k) submissions to FDA to ensure Medacta products can be distributed in the US

·        Supports the necessary communication to FDA as part of the 510(k) submissions being managed

·        Coordinates all recall, correction, and removal activities within Medacta USA

·        Coordinates the FDA yearly establishment registration as well as all device listings

·        Provides support for all import documentation / clearance requests

·        Supports the review of regulatory intelligence to understand changing regulations 

·        Provides support for all hospital contract requests

·        Supports quarterly quality system audits to ensure the Medacta USA quality management system is effective and in compliance with FDA 21 CFR Part 820 regulations

·        Develops and implements standard processes to ensure consistent and repeatable results

·       Ensures that all quality system activities are completed in compliance with 21 CFR Part 820 regulations

C.        Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.