Senior Regulatory Compliance Expert for Medical Devices
4 weeks ago
Company Overview
WS Audiology is a market leader in the hearing aid industry, driven by a passion to improve quality of life.
We are accelerating our business transformation to reach more people effectively.
Job Description
As a Global Senior Regulatory Affairs Specialist, you will ensure WSAudiology products meet the highest compliance standards.
You will be integral to our day-to-day regulatory problem-solving and collaborate with our global Regulatory Affairs team and stakeholders.
Your mission will be to provide expert guidance and support, ensuring robust regulatory strategies and upheld compliance standards.
You will manage interactions with HQ and global stakeholders while building confidence in your advice and support.
Main Responsibilities
- Serve as a primary knowledge resource for EU MDR, US FDA 21 CFR 820, and ISO 13485 regulations.
- Lead Regulatory Affairs problem-solving initiatives and manage regulatory projects from concept to completion.
- Provide expert guidance on Classification, Intended Use, labeling requirements, and Declaration of Conformity for hearing instruments, medical apps, and related accessories.
- Act as Subject Matter Expert (SME) on Regulatory Affairs during audits and inspections, ensuring compliance and addressing regulatory concerns.
- Manage CAPA processes related to Regulatory Affairs, ensuring timely and effective resolution of issues.
- Contribute to the development and execution of the Global Regulatory Affairs strategy, driving continuous improvement and regulatory excellence.
Candidate Profile
The ideal candidate has a proven track record as a Global Senior Regulatory Affairs Specialist and Project Lead in a complex organization.
Demonstrated success in embedding a strong compliance culture throughout the entire organization.
The ideal candidate should possess:
- A relevant Master's degree in Engineering, Natural Science, or Technology.
- +5 years of experience working as an RA professional in medical devices in EU and the US.
- Experience with optimization of global/international regulatory affairs processes.
- Experience in interacting with regulatory authorities.
- Thorough knowledge of medical device regulation; EU MDR, US FDA 21 CFR 820, and ISO 13485.
- Interest in learning about the Radio Equipment Directive (2014/53/EU) and Global Radio Equipment requirements for Medical Devices.
Estimated Salary
$120,000 - $160,000 per annum, depending on qualifications and experience.
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