Principal Regulatory Affairs Specialist
True Digital Surgery is a World Leader in Computer-Guided Microsurgery. We combine 3D visualization and guidance software applications focused on improving accuracy, efficiency and outcomes for surgeons and patients. Our medical imaging and guidance system employs advanced real-time 3D graphic capabilities and proprietary software that is sold to surgeons and hospitals all over the world.
The Principal RA Specialist will serve as the TDS RA subject matter expert providing leadership, strategic planning as well as high quality technical support for implementation of TDS digital surgical microscope (DSM) and related navigation product line(s) RA market clearance.
The Principal RA Specialist will primarily work on new product development and be responsible to executive management, commercial teams and program teams developing and implementing regulatory strategy, device classification (typically Class I and Class II), predicate identification, clinical protocols, clinical evaluation, clinical evaluation reports and regulatory submissions leading to global market clearance and device registrations.
In addition to new product development, the Sr RA Specialist will be responsible for the assessment of released device changes for regulatory implications and for performing regulatory activities in support of implementing device changes.
The Principal RA Specialist will need to work collaboratively with external partners, consultants, regulatory authorities, outside labs, critical and/or strategic suppliers as well as internal stakeholders such as Program Management, Product Management, Engineering, Operations, Purchasing, Customer Support, Technical Service and the True Digital Surgery senior management team.
ESSENTIAL DUTIES AND RESPONSIBILITIES
include the following. Other duties may be assigned.
- Understands and is familiar with appropriate regulatory standards and how to apply them to products and processes efficiently (including but not limited to ISO 13485, FDA 21 CFR 820, EU MDR Regulation 2017/745 and IEC 60601).
- Interface with FDA, EU competent authorities, notified bodies and other regulatory agencies as required
- Make recommendation for product RA approval strategy via literature search and candidate predicate search. Establish device classification, predicate strategy, clinical protocols, clinical evaluations, clinical evaluation reports.
- Submit regulatory submissions and device registrations
- Identify, screen and sub-contract with RA consultants where needed to supplement the TDS team
- Manage technical files for both new product development and design changes to existing products – Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Risk Management File (RMF), Input Output Verification Validation (IOVV) output, Clinical Evaluation Reports etc are complete and meet all governmental regulatory requirements using checklists supplied by the governmental agencies ready for regulatory agency filing.
- Evaluate proposed engineering / product / manufacturing changes made to a released product and advise if there is any impact to the regulatory filing, Technical File and/or notification of change to governmental agencies required. Help implement the changes required.
- Coordinate outside lab quoting, prepare and attend testing, author or contribute and review test protocols / reports
- Understand and review test protocols / test reports submitted and issue correction requests to the author(s) as necessary
- Author and/or review comprehensive test protocols and protocol test reports and ensure that all applicable governmental requirements are met /included in the protocol 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
- Participate in design reviews and provide regulatory guidance as necessary
- Post Market Surveillance and Vigilance regulatory compliance
- Provides ongoing input and ownership of RA updates to the Quality Management Systems
- Maintain external standards database with most recent standards for use by development teams
- Continuous Process Improvement (CPI) of TDSs Quality Management System, Processes, Templates, Work Instructions and Forms for compliance with ISO 13485:2016 and EU MDR Regulation 2017/745
- Develops technical documents that are clear, concise, and complete to facilitate reviews/approvals.
- Work in a highly professional team environment with external and internal stakeholders
- Drives superior results by taking initiative, planning, and implementing projects, setting priorities and holding self and others accountable to meet commitments
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.
BS Degree with 15+ years of industry experience (or) MS Degree with 10+ years of industry experience in Engineering, Health, Biomedical or Quality Regulatory Engineering in a RA management or leadership role with lead regulatory responsibilities for a medical device company. Candidates with expert working knowledge of FDA and EU MDR Regulation 2017/745 for device classification II, IIa and/or IIb is required. Working knowledge of DHF/DMR/DHR/RMF/Technical File/V&V/Post Market Surveillance and Vigilance required. Candidates should be comfortable working in a high-paced environment with complex system solutions involving HW, SW, Optics, Imaging, Robotics and Navigation used in a medical device.
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.
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.
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.
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 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.