Greg Calder Email and Phone Number
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Greg Calder personal email
• Highly effective seasoned Regulatory Affairs leader with solid accomplishments promoting business growth• Unique combination of business acumen, global regulatory compliance knowledge, and medical device product design and development expertise• Led teams to obtain multiple FDA 510(k) clearances for Class II devices regulated by CDRH and CBER• Provided clear and effective Regulatory guidance and project management for multiple simultaneous new product development and continuous improvement projects in a fast paced, matrixed, multinational work environment• Expert electrical, software and systems test engineering background with substantial verification and validation experience
Fresenius Medical Care North America
View- Website:
- freseniusmedicalcare.com
- Employees:
- 49625
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Fresenius Medical Care North AmericaWaltham, Massachusetts, United States
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Senior Director | Regulatory Project Management & OperationsFresenius Medical Care North America Mar 2023 - PresentBad Homburg, Frankfurt, De
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Director, Regulatory Affairs DevicesFresenius Medical Care North America Jan 2016 - Mar 2023
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Manager Regulatory AffairsFresenius Medical Care North America May 2014 - Jan 2016Bad Homburg, Frankfurt, De
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Principal Regulatory Affairs AssociateFresenius Medical Care North America Apr 2013 - May 2014Bad Homburg, Frankfurt, DePrincipal 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.
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Manager, Regulatory AffairsHaemonetics Jun 2011 - Mar 2013Boston, 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. -
Regulatory Affairs SpecialistHaemonetics Oct 2008 - Jun 2011Boston, 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.
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Sr. Software And Systems Test EngineerHaemonetics Jan 1994 - Oct 2008Boston, 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.
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MultipleHaemonetics Aug 1984 - Jan 1994Boston, 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.
Greg Calder Skills
Greg Calder Education Details
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Northeastern UniversityTechnical Writing; Software Engineering -
Blue Hills Technical InstituteElectrical Engineering Technology
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Foxboro High School
Frequently Asked Questions about Greg Calder
What company does Greg Calder work for?
Greg Calder works for Fresenius Medical Care North America
What is Greg Calder's role at the current company?
Greg Calder's current role is Senior Director | Regulatory Project Management & Operations at Fresenius Medical Care North America.
What is Greg Calder's email address?
Greg Calder's email address is g.****@****zon.net
What schools did Greg Calder attend?
Greg Calder attended Northeastern University, Blue Hills Technical Institute, Foxboro High School.
What skills is Greg Calder known for?
Greg Calder has skills like Fda, Medical Devices, Capa, Regulatory Affairs, Iso 13485, R&d, Design Control, Quality System, Validation, Product Development, Iso 14971, V&v.
Who are Greg Calder's colleagues?
Greg Calder's colleagues are Monique Gregory, Lisa Pruitt, Joel Borines, Rita Carlotto, Mpho G., Benjamin Wünsch, Michelle Albright.
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