Position Summary

The Regulatory Project Manager position manages Medacta USA’s regulatory strategy.  This includes coordination and completion of necessary product priorities, development and implementation of department processes and procedures, and support for the Medacta USA operations, R&D, marketing, and sales teams.

 

Job Specifications

 

 

A.

Knowledge:

1

Minimum Educational Requirements

Bachelor’s Degree in Life Science or Engineering field or an associate’s degree in conjunction with 5+ years’ experience in the medical device field is required.   

 

 

 

 

2

Minimum Experience Requirements

5 - 7 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 throughout all levels of the company.  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 preferred, yet not required.

 

 

 

4

Equipment or Machines Used

PC, Microsoft Office software suite, general office equipment.

 

 

 

B.       Principal Duties

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

·        Serves as the applicant correspondent for 510(k) submissions and coordinates the necessary communication between R&D, marketing, other Medacta departments and FDA

·        Supports the development and implementation of the regulatory strategy for Medacta USA

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

·        Provides support for all import documentation requests

·        Manages the review of all forms of regulatory intelligence to understand changing regulations and their impact to Medacta USA 

·        Provides support for all hospital contract requests

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

·        Identifies opportunities to reduce common deficiencies from FDA

·       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.

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