Greg Calder Email & Phone Number

Waltham, Massachusetts, United States

Bad Homburg, Frankfurt, De

Bad Homburg, Frankfurt, De

Bad Homburg, Frankfurt, De

Principal Associate, Regulatory Affairs (April 2013 – May 2014)• Under direction of senior department management, was responsible for the day to day oversight and management of assigned projects.• Served as the primary regulatory resource for changes to and prioritization of projects, resource assignment and efficient management of the development and change process.• Provided leadership and direction to assigned resources.• Provided guidance to development teams on regulatory requirements for product development and design changes for both domestic and international markets.• Responsible for the preparation of FDA submissions for clearance of new products.• Responsible for the preparation of Regulatory Assessments and Notes to File for assigned projects.• Independently reviewed and approved relevant documents, including engineering changes, advertising and promotional materials and product development reports.• Developed and maintained regulatory procedures and policies to ensure ongoing compliance of existing and new products.

Boston, Ma, Us

• Managed RA team of two RA professionals at two US sites including Braintree, MA (dry set devices) and Covina, CA (RA labeling and Advertising and Promotion).• Led RA teams to obtain multiple Traditional 510(k) clearances through both CBER and CDRH in STED like format. All submissions were cleared without Additional Information (AI) letters in 90 days or less.• Managed multiple worldwide product recalls and recall closures.• Compiled and wrote submission documents and responses for product approvals for the US FDA and Health Canada including 510(k) Premarket Notifications, Technical Files, Canadian Medical Device License applications and amendments, and appropriate follow-up responses and reports.• Provided regulatory training and guidance to product development teams to assure appropriate standards and regulations were followed.• Participated in CAPA investigations, DFMEA, PFMEA and Hazard Analysis risk assessments.• Wrote MDRs and Recall Notifications to FDA and Health Canada, and conducted field corrections and recalls.• Communicated with customers in response to regulatory concerns or questions.• Maintained product registration database for foreign registrations.• Worked closely with international regulatory affairs subsidiaries to support distribution markets in coordinating product registrations.

Boston, Ma, Us

• Compiled and wrote submission documents and responses for product approvals for the US FDA and Health Canada including 510(k) Premarket Notifications, Technical Files, Canadian Medical Device License applications and amendments, and appropriate follow-up responses and reports.• Obtained clearance for two 510(k)s from CDRH and one 510(k) from CBER.• Provided regulatory training and guidance to product development teams to assure appropriate standards and regulations were followed.• Participated in CAPA investigations, DFMEA, PFMEA and Hazard Analysis risk assessments.• Wrote MDRs and Recall Notifications to FDA and Health Canada, and conduct field corrections and recalls.• Communicated with customers in response to regulatory concerns or questions.• Maintained product registration database for foreign registrations.• Worked closely with international regulatory affairs subsidiaries to support distribution markets in coordinating product registrations.

Boston, Ma, Us

• Responsible for establishing system verification credentials for medical device software and systems across all Haemonetics’ product lines.• Planned and executed system verification activities for multiple medical device projects.• Designed, developed and executed test procedures and processes to track, debug, verify and validate medical device embedded software systems.• Responsible for the establishment of software verification credentials for medical device software systems across all Haemonetics’ product lines.• Developed a software defect tracking and reporting system that brought visibility and accountability to software defects.• Planned, designed and executed test procedures to verify and validate embedded software to demonstrate efficacy across all product lines.• Performed Site Monitor responsibilities for various clinical trials.

Boston, Ma, Us

• Technical Writer - Medical device service manuals.• Product Support and Training - Medical device product support including employee and customer training.• Field Service Engineer - Medical device service and customer service.• Reliability Engineering Technician - Medical device component failure analysis.• Quality Control Technician - Medical device manufacturing.

Technical Writing; Software Engineering

Aset, Electrical Engineering Technology

Education record