Regulatory Compliance Manager

vor 2 Wochen

Innsbruck, Österreich Nissha Medical Technologies Vollzeit

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.

**Responsibilities**:
Develop and implement regulatory strategies for global clearances to market new products, maintain existing products, prepare submissions dossiers and facilitate clearance with regulatory agencies.
- 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.
- Review design changes made to ensure the legacy medical device technical files are accurate to the current design of the device; identify gaps.
- 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.
- Compile all materials required for device submissions, license renewal and annual registrations.
- Assess change impacts to products and processes and initiate regulatory actions to maintain market access.
- Recommend changes for labeling, manufacturing, and marketing for regulatory compliance.
- Keep abreast of regulatory procedures and changes in target markets
- May direct interaction with regulatory agencies on defined matters
- Support regulatory strategy plans to identify actions required for market access.
- 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.
- Demonstrate knowledge and act in accordance with NMT's Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.
- Support the establishment of quality standards for products, processes, and procedures.
- Participate in internal and external audits

**Qualifications**:

- 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.
- Bachelor's Degree (BA or BS) from a four-year College or University

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