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Regulatory Compliance Manager Role, Innsbruck
J191525_1678979809 Austria €60K / Year
We currently working on a very high-profile vacancy for an international client in the medical device industry.
In the Regulatory Compliance Manager role, you will be 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.
Territory Details
- n/a
Key Duties
- 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.
Package and Benefits
- up to €60,000
Key Skills, Qualifications and Client requirements
- 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
What Happens Next?
If you are interested in finding out more about this role please click the 'Apply' button. On submission of the job application form, an email alert is sent to the specialist consultant handling this role to register your interest.
All dialogue with us is in the strictest of confidence, without any obligation and we will NOT send your details to the relevant business without your consent.
Alternatively, to find out more about this role or any other roles that maybe relevant, you can email us at [email protected] or call our Medical Devices team on 01423 813456
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