XE
Xcel EnergyRegulatory Policy Specialist
Regulatory Policy Specialist developing regulatory case filings and strategies at Xcel Energy. Collaborating with senior management to ensure compliance and effective communication with stakeholders.
About the role
- Prepare and review global regulatory submissions including US 510(k), US Class III Annual Reports, US PMA/HDE Supplements and EU MDR technical documentation
- Support regional regulatory colleagues in preparation of international regulatory submissions for new and modified devices
- Serve as RA lead on project teams to develop regulatory strategies, testing requirements and documentation to meet product launch timelines
- Manage/lead regulatory-driven projects and execute global regulatory strategies for product release and market expansion
- Maintain knowledge of global regulations, standards, guidance documents, country-specific requirements, internal procedures, medical devices and medical terminology
- Maintain computer databases for cleared/approved product release, UDI database accuracy, and submission tracking/metrics
- Plan, lead and support internal and Regulatory agency audits and engagement with regulatory authorities
- Lead regulatory assessments for engineering change requests and manage updates to registrations
- Develop and maintain company global and local SOPs to assure regulatory compliance
- Provide technical guidance and regulatory training/mentoring to Regulatory Affairs employees and cross-functional teams
- Develop/review product labeling (IFUs, PICs, PILs), Surgical Techniques and promotional materials for regulatory compliance
Requirements
- Bachelor’s degree preferably in a clinical, medical, or scientific/technical discipline (Biomedical engineering preferred)
- Minimum of 5 years regulatory experience within the medical device industry
- Orthopedic device experience desired
- 510(k) experience is required
- PMA/HDE experience preferred
- Demonstrated experience with successful regulatory submissions in key markets such as the US and EU
- Demonstrated knowledge of regulatory requirements, standards and guidance for medical devices
- Experience working with large cross functional teams and diverse groups
- Processes and Product Lifecycle Management Systems experience is required
- Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP)
- Ability to write detailed technical regulatory submissions, reports and business correspondence
- Willingness to travel: <10%
- Position does NOT offer visa transfer or sponsorship (must have work authorization)
Benefits
- 401k Matching Program
- 401k Plus Program
- Discounted Stock Options
- Tuition Reimbursement
- PTO (Paid Time Off)
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical, Dental, Vision
- Health Savings Account (Employer Contribution of $500+ annually)
- Employee Assistance Program
- Parental Leave
- Fertility and Adoption Assistance Program
- Hybrid Work Model (For most professional roles)
- Discounts on fitness clubs, travel and more
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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