Job Summary
This position is responsible for activities concerned with the review, development, remediation, and approval of Device History Files and/or Technical Documentation of medical devices.  Activities will also include the preparation of regulatory submissions in all markets.   Essential responsibility includes ensuring compliance to the applicable Quality Management System by performing the essential functions and basic duties outlined in this job description. Other responsibilities include interfacing with other departments and customers on regulatory related aspects of projects.

Essential Job Functions
1. Develop and implement regulatory strategies for global clearances to market new products, maintain existing products, prepare submissions dossiers and facilitate clearance with regulatory agencies.
2. Review current state of legacy medical device technical files to identify any gaps in compliance with procedures and requirements of FDA 21 CFR and Medical Device Regulation 2017/745.
3. Review design changes made to ensure the legacy medical device technical files are accurate to the current design of the device; identify gaps.
4. Supports new product Design Control process as relates to regulatory inputs and decisions, participates in generation of product requirements, risk analysis, labeling and other design control document.
5. Compile all materials required for device submissions, license renewal and annual registrations.
6. Assess change impacts to products and processes and initiate regulatory actions to maintain market access.
7. Recommend changes for labeling, manufacturing, and marketing for regulatory compliance.
8. Keep abreast of regulatory procedures and changes in target markets
9. May direct interaction with regulatory agencies on defined matters
10. Support regulatory strategy plans to identify actions required for market access.
11. Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
12. Demonstrate knowledge and act in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
13. Support the establishment of quality standards for products, processes, and procedures.
14. Participate in internal and external audits.

Requirements

• Bachelor’s Degree (BA or BS) from a four-year College or University 
• Minimum of 3 years of related experience (Medical Device preferred)
• Familiarity with Quality Systems and regulatory agencies. Preferably ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820.
• Experience in submission of 510(k) Premarket Notifications and identifying predicate devices, Premarket Approvals (PMAs), and CE Technical Documentation/ Dossiers. 

Knowledge, Skills & Abilities

• Highly organized, detail oriented and works effectively as both a team member and independent contributor
• Demonstrated proficiency in MS Suite, particularly MS Word and Excel
• Ability to work independently at time with minimal supervision
• Acts with sound and proactive decision making, seeks clarification as appropriate to minimize/eliminate delays
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals
• Ability to write routine reports and correspondence
• Ability to apply logical and systematic understanding to carry out instructions furnished in written, oral or diagram form.
• Ability to deal with problems involving several concrete variables in standard situation

Some travel may be required.

​Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, gender expression,national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process, please call 716-849-6495.