Rebecca Astrup Email & Phone Number

Elk River, Mn, Us

Responsible for the preparation and maintenance of market authorizations for interventional cardiology products in the US, EU, and Canada. -Develop and execute regulatory strategies for new product development. -Author market authorization submissions for FDA, Health Canada, and the EU. Examples include: -FDA: 510(k), PMA, IDE -Health Canada: Class II, Class IV (ToC), ITA -EU: Technical File (Class II), Design Dossier (Class III), Notice of Change-Review labeling, promotional material, product changes and assess regulatory impact, including regulatory file memo generation. -Provide ‘Regulatory 101’ training for cross-functional departments. -Present regulatory strategies to cross functional and leadership teams. -Participate in internal and external audits, including audit preparation, front room facilitation, and back room lead roles.

Minneapolis, Mn

Provide support services to achieve and maintain global regulatory compliance. Lead responsibility for the regulatory product release process and wholesale drug distributer/manufacturer licensing program. Responsible for training, mentoring, and management of three dotted line reports.-Completed Oracle transactions to remove or apply regulatory holds, following the evaluation of a product for release.-Evaluated product labels to ensure compliance with international regulatory and local language requirements and verify registration/market authorizations were in place for product release.-Maintained wholesale drug distributer/manufacturer licenses for multiple facilities throughout the US. -Fulfilled Certificate to Foreign Government (CFG) requests.

Maple Grove, Mn

Responsible for the ongoing maintenance, effectiveness, and improvement of quality system programs. Lead responsibility of the non-conforming product, out of calibration reporting, management review, and quality system training programs. -Supported the migration of quality system processes from an access database system to the Agile PQM system. Migration activities included establishing new workflows, rewriting standard operating procedures, and training process users. -Responsible for coordinating responses to audit findings including conducting and summarizing root cause investigations and CAPA.-Presented GMP training, including gowning requirements, good documentation practices, and line clearance to new hires. -Conducted internal and supplier audits from generation of the audit plan to the final audit report. Reviewed audit response action plans for adequacy. -Collected and analyzed metrics for management review on a quarterly basis. Presented data to department leaders.

Brooklyn Park, Mn

Manage day-to-day office operations in a fast paced, Contract Research Organization. Collaborate with a group of regulatory, quality, and clinical consultants to effectively implement and maintain quality systems and coordinate paperwork for regulatory submissions for medical device startup companies.-Route quality system documentation for approval. Audit quality system files, design history files, and training records.-Perform product registration in Latin America.-Enter data for clinical trials into the MAESTRO CTMS system.-Maintain office efficiency by managing the inventory and ordering of office supplies and equipment.-Encourage a highly engaged company culture by planning company events and team building activities.

Brooklyn Park, Mn

**Temporary Contract Position**Operated within the quality assurance department to ensure compliance with recognized standards, customer specifications, and good manufacturing practices in a laboratory setting.-Reviewed raw test data and test reports for sterility, bioburden, and environmental monitoring to ensure tests were performed correctly and test results reported accurately-Reviewed and revised standard operating procedures to improve clarity and usability.

Eagan, Mn

Operated independently and in collaboration with a group of microbiology lab technicians and study directors to evaluate, interpret, and perform a wide range of chemical and microbiological assays while conforming to Standard Operating Procedures and Good Laboratory Practices.-Collaborated with study directors to execute disinfection qualification studies from research and development stages to generation of GLP compliant data for FDA submission-Executed disinfection validations for reusable medical devices in support of 510(k) submissions.-Generated documentation for the cleaning, maintenance, and monitoring of laboratory equipment such as incubators, spectrophotometers, centrifuges, balances, freezers, and refrigerators-Worked closely with the quality assurance unit to generate and maintain GLP compliant documentation-Expedited the ordering and maintaining of laboratory supplies and materials by generating an Excel database of expiration and received dates for commonly used laboratory material

Bachelor Of Science (B.S.), Biology

Activities and Societies: Beta-Beta-Beta, Psi-Chi, ACS Microbiology Research Project- Collaborated with a small group of students.

Associate Of Arts (A.A.)