Hilary Ann Baldwin
Tempe,Arizona
Summary
High-performing individual with over 15 years of experience in medical device and pharmaceutical environments. Enthusiastic professional with excellent people skills and dedicated work ethic. Demonstrated track record of success for implementing new processes.
Overview
18
18
years of professional experience
Work History
Staff Regulatory Affairs Specialist
Stryker Sustainability Solutions
Tempe, AZ
11.2015 - Current
- Self-directed with insightful judgment skills. High level of personal accountability.
- Contributed substantially to successful division MDSAP accreditation.
- Established and oversaw implementation of project plan and budget as the project manager for international market penetration.
- Strategically planned the regulatory strategy and prepared submissions to penetrate Canada, EU, and Japan markets to achieve operational goals and targets.
- Worked as liaison both internally and externally to develop success relationships with regulatory bodies.
- Served as regulatory contact for the sales force domestically and internationally.
Senior Regulatory Affairs Specialist
Ulthera, Inc.
Mesa, AZ
02.2015 - 11.2015
- Obtained documents, clearances, certificates and approvals for over 25 countries.
- Provided regulatory strategy for successful submission and launch of new devices.
- Prepared 510(k), Technical, and other international submissions.
- Performed User Case Studies for the sales force.
- Prepared all documentation for successful ISO 13485 audit.
External Laboratory Management Services
Covance Laboratories
Indianapolis, IN
05.2013 - 01.2015
- Gathered and analyzed supplier, inventory ,and test lab requirements to assess areas in need of improvement.
- Maintained optimal inventory levels of testing reagents and equipment to meet operational requirements.
- Collaborated with Sales and Business Development to develop scopes and implement project plans.
- Strengthened company's business by leading implementation of SAP.
- Maintained project quality with a hands-on management style of all accounts.
- Cultivated and strengthened lasting client relationships.
- Delivered customized and effective solutions to clients that met unique demands.
- Oversaw up to 150 labs at a time without sacrificing standards.
Supervisor II-Bio analytical Laboratory
Covance Laboratories
Indianapolis, IN
02.2012 - 05.2013
- Developed and enforced safety standards and procedures for laboratory testing and quality purposes.
- Supervised Technical and Operations staff..
- Served as contact for early development lab for internal and external clients.
- Represented Division on several cross-site and global projects.
- Assisted with the development and administration of laboratory budgets.
- Maintained equipment and facilities in good working order.
- Cooperated and communicated effectively with physicians and clinical investigation sites to ensure client satisfaction and compliance with set standards.
Technical Team Lead (contractor)
Lilly Research Laboratories
Indianapolis, IN
03.2009 - 02.2012
- Coordinated with internal clients to finalize designs and confirm requirements.
- Oversaw the In Vivo, In Vitro, and Metabolism laboratories in 5 on-site buildings.
- Served on validation review and medical review boards.
- Hosted client and regulatory agency audits.
- Performed internal audits.
Project Lead
Roche Diagnostics Operations
Indianapolis, IN
02.2006 - 12.2008
- Defined the responsibilities and roles of 25 team members.
- Planned, executed and promoted a total of 3 remediation projects in 2 years.
- Monitored progress and examined the risks of various projects, including setting forth contingency plans.
- Set up and managed team meetings.
- Streamlined and enhanced the quality control lab process for successful completion of the remediation projects.
- Consistently met deadlines and requirements for all commitments to the regulatory bodies.
- Designed strategic plan for the development practices to support future remediation projects as required.
Education
Bachelor of Science - Chemistry with Biochemistry Emphasis
Loyola University of Chicago
Chicago, IL2004
Skills
- Proficient in MS Office
- Excellent time management
- Excellent sense of direction
- Project management
- Global logistics
- Product lifecycle
- Budget management
- Fast learner
- Quality management systems knowledge
Timeline
Staff Regulatory Affairs Specialist
Stryker Sustainability Solutions
11.2015 - Current
Senior Regulatory Affairs Specialist
Ulthera, Inc.
02.2015 - 11.2015
External Laboratory Management Services
Covance Laboratories
05.2013 - 01.2015
Supervisor II-Bio analytical Laboratory
Covance Laboratories
02.2012 - 05.2013
Technical Team Lead (contractor)
Lilly Research Laboratories
03.2009 - 02.2012
Project Lead
Roche Diagnostics Operations
02.2006 - 12.2008
Bachelor of Science - Chemistry with Biochemistry Emphasis
Loyola University of Chicago
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