Uptake Medical Technology is seeking a full-time Regulatory Affairs Manager. This exciting organization has a strong set of values and commitment to employees and patients. This is a special opportunity to join an expertly managed, privately held, commercial stage interventional pulmonology medical device company.
Reporting to the VP of Regulatory and Quality, you are responsible for global regulatory submissions, global product registrations, global complaint handling and general regulatory compliance support.
Essential Duties and Responsibilities:
- Prepare and support regulatory submissions (Design Dossiers, Technical Files, IDE, Notified Body Submissions, PMAs, 510(k)s, revisions/supplements, etc.) in a timely manner, meeting current regulations and guidance document requirements
- Facilitate site registrations in targeted countries and ensure compliance to applicable regulations.
- Maintain FDA registration and export documentation as needed.
- Implement a complaint program that is compliant with MDR & Vigilance requirements and additional requirements as needed based on targeted countries.
- Coordinate field complaint review along with Director of Operations
- Analyze complaints to assess reporting requirements and address as applicable. Ensure that reportable events are handled in accordance with MDR, Vigilance, and additional requirements as applicable in targeted countries.
- Review labeling (including IFU), publications and promotional material to ensure claims related to medical device safety and efficacy can be substantiated
- Maintain Master Standards List, and ensure that updated legislation and revisions are assessed for impact and implemented as appropriate.
- Communicate recommendations for regulatory strategies including regulatory pathways, compliance test requirements, substantial change notifications to notified body, and responses to queries from FDA, Notified Body, TGA and other targeted commercial countries.
- Participate in risk management reviews
- Prepare and submit annual reports
- Support review of clinical documentation including protocols and reports.
- Review plans, FMEAs, verification and validation protocols and reports, for internal consistency, standards application and effects on submissions.