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Regulatory Affairs Staff Specialist

About True Digital Surgery®

With a nearly two-decade legacy of creating cutting-edge medical devices, True Digital Surgery® is advancing its innovative 3D surgery digital platform through the integration of optics and robotics with augmented reality and machine learning that result in life-extending outcomes for both surgeons and patients.

 

SUMMARY

The Regulatory Affairs Staff Specialist will participate in all Regulatory Affairs activities for foreign and domestic communications.

The RA Staff Specialist will be an integral factor to ensure that the latest requirements as stipulated by foreign and domestic health regulatory agencies are included in the TDS document system. The Staff Specialist should know how to participate in communications (as necessary) with foreign and domestic health regulatory agencies as well as all current and potential customer regulatory / quality assurance personnel.

The RA Staff Specialist should also be competent / familiar with processes for filing appropriate regulatory submissions and interpreting the impact of design changes on regulatory adherence.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

· Promote company-wide awareness of the company's regulatory requirements

  • Forming filing strategies post design feasibility reviews for the product
  • Prepare the necessary government forms and compile complete and accurate report(s) that will be submitted to support the submission strategy of the product created by TDS.
  • Interface with FDA, EU authorities and other regulatory agencies as required
  • Evaluate the engineering / product / manufacturing changes made to a current cleared device and advise if there is any further information that must be generated to support the change and subsequent notification of the change to governmental agencies
  • Directly responsible for post market studies / evaluations of the released product and report any perceived product problems to the engineering team for further action(s) that must be engaged

· Author comprehensive test protocols and protocol test reports and ensure that all applicable governmental requirements are met /included in the protocol reports

· Manage technical files for all products created – ensure that the technical (design history files) are complete and meet all governmental regulatory requirements using checklists supplied by the governmental agencies.

· Prepare / coordinate outside testing as requested and review the test protocols / reports

· Understand labeling, user requirements, instructions for use, indications for use documents and know how they are applied to the class device to be released for sale

· Understand and review test protocols / test reports submitted for review and issue correction requests to the author(s) as necessary

· Perform clinical data research for pertinent clinical manuscripts using data bases such as PubMed, COCHRAN, EMBASE, etc.

· Provide the proper regulatory guidance to design development teams and complete any necessary reports / executive summaries

· Provide assistance in the review of communications from customers and government agencies

· Participate in design reviews and provide guidance as necessary

· Stay up to date with current regulations and state of the art matters as they pertain to the device(s) created by TDS and any other pertinent documents that may apply.

· Working knowledge of US FDA CFR 820 Quality System Regulations and EU MDR 2017/745 is a plus

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience

Candidates with a Bachelor of Science Degree in Biomedical or Quality Engineering or Biology, Chemical, Physiology is strongly preferred. Or equivalent medical device industry work experience of two to five years related experience and/or training, or equivalent combination of education and experience would be considered.

Candidates with the additional working knowledge of the differences of Class I or II, IIa, IIb Medical Devices is a big plus and including a working knowledge of design history / technical file management , V&V testing , FMEA creation, risk analysis for medical devices is strongly recommended.

Candidates should be comfortable working in a high-paced environment with robotics, software used in a medical device, and technical writing.

Computer Skills

To perform this job successfully, an individual should have knowledge of Microsoft Office including Word, Excel, Outlook; and Database software. Knowledge of the e-filing for US FDA applications for medical devices is a plus.

 

Physical Requirements

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

While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 50 pounds and frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include color, distance and close vision.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.

Benefits:

We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment

To Apply:

To respond to this opportunity, please apply through this ad.

For more information about us, please visit www.truedigitalsurgery.com

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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