Regulatory Associate I

Medacta® is a Swiss-based orthopedic company founded in 1999, renowned for its innovative products and surgical techniques. Notably, they pioneered the Anterior Minimally Invasive Surgery (AMIS®) technique for hip replacements, leading to minimally invasive approaches. Leveraging their extensive orthopedic expertise, Medacta introduced MySolutions technology, which provides surgeons with highly personalized pre-operative planning and implant placement methodologies. Utilizing advanced personalized kinematic models and 3D planning tools, MySolutions enhances surgical precision in hip, knee, shoulder, and spine procedures. Medacta's blend of orthopedic expertise and cutting-edge technology drives continual advancements in the field, enhancing patient care worldwide.

Educational Requirements:

Bachelor’s Degree in Life Science or Engineering field.

Experience Requirements:

1 - 2 years’ experience in medical device regulatory is preferred.

Required Skills and Abilities:

• 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 manage multiple tasks concurrently.
• Excellent time management skills.
• Demonstrated knowledge of FDA medical device quality system regulations is a plus.
• Physical Requirements:
  • Sitting: Extended periods at a desk or workstation.
  • Standing and Walking: Occasional movement within the office.
  • Lifting and Carrying: Light to moderate lifting of office materials.

Additional tasks may require reaching, manual dexterity, and visual acuity.

External: N/A

Internal: Quality and Regulatory colleagues, Sales Personnel, Marketing, Product Development, Finance, Administration, Customer Service, Operations, Clinical Research, and Medacta International Personnel worldwide.

Travel requirements: Some travel to industry conferences is possible.

Extent of Confidential Information: Any regulatory submission and any Protected Health Information

Reporting: Regulatory updates to internal colleagues

• Serves as the primary Medacta USA contact for customer complaints and submits the initial complaint notifications to Medacta International.
• Coordinates the development of 510(k) submissions to FDA to ensure Medacta products can be distributed in the US.
• Coordinates all recall, correction, and removal activities within Medacta USA.
• Supports the review of all CAPA’s (Corrective and Preventive Actions)
• Coordinates the FDA yearly establishment registration as well as all device listings.
• Provides support for all import documentation requests.
• 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. 
• Performs other related duties as assigned.

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.