The Director, Regulatory Affairs will serve as the RA subject matter expert providing leadership, strategic planning as well as high quality technical support for implementation of digital surgical microscope and related navigation product line(s) RA market clearance. You 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 Director, Regulatory Affairs 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 Director, Regulatory Affairs 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
- 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 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 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
- 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.