Regulatory Policy Specialist developing regulatory case filings and strategies supporting company goals at Xcel Energy. Collaborating with stakeholders and senior management to ensure compliance and effective communication.
About the role
- IVDR Expert managing regulatory submissions for IVD products at SOPHiA GENETICS. Collaborating with teams across Europe and North America in a hybrid work environment.
Responsibilities
- Responsible for driving the strategy and delivering the execution on submission for our transition from IVDD to IVDR for selected products.
- Provide strategic regulatory guidance for IVDR Class C and higher IVD and CDx products.
- Drive and coordinate the development and execution of regulatory strategies and submission plans to support our IVDD products through to IVDR approval.
- Lead regulatory submission efforts including EU Clinical Trial Assays (CTAs), Ethical Approvals, and Notified Body filings.
- Serve as the primary point of contact for IVDR-related projects internally and externally (e.g. with Notified Bodies).
Requirements
- 5+ Years Regulatory Affairs experience within Diagnostics or Medical Devices
- Proven track record of successful IVDR Class B, C or D submissions and approval
- Direct working knowledge of either IVDR submission for software-based devices or NGS-based diagnostics (ideally both). EN/IEC 62304 Beneficial.
- Experience of working is EU Notified Bodies / Regulatory Authorities essential
- Knowledge of oncology regulatory frameworks and diagnostic development highly beneficial
- Fluency in English required
Benefits
- Outstanding Medical, Dental & Vision with 90% Employer Contribution
- Company matched 401K at 4%
- Company-paid short & long-term disability insurance
- FSA commuter benefits
- 20 Days PTO, increasing to 25 with tenure; 5 Days Sick and 14 Public Holidays
- Free EAP
- Sickness and Accident coverage through Helsana
- Meal Vouchers at 90CHF PM with our partner cafeteria
- A fun and engaging work environment, with Rest & Entertainment space, full stocked free coffee machine and free fruit/snacks
- Free parking in an easy to access location
- A strong social committee whose purpose is to make SOPHiA GENETICs both enjoyable as well as rewarding
- Direct interaction and exposure to senior leadership and our executive team locally
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