FDA resumes in Northborough, MA

Watertown, MA
... Adept at building credibility and working effectively with senior management, engineers, quality managers, manufacturers, FDA, EU and other global regulators to identify and manage the most optimal regulatory path to market for the organization(s). ... - 2020 Mar 06

Chelmsford, MA
... Represented the marketing team’s interests as part of weekly review process for regulatory/medical/legal approvals of digital marketing content before FDA submission. Interfaced with 5 different agencies to create more than 40 digital ads, three ... - 2020 Mar 05

Watertown, MA
... August- December 2017 Development Co-op: Packaging and Case Development (Zimmer Biomet, Warsaw, IN) ● Responsible for complying with FDA requirements for case functionality and new product development. ● Performed risk analysis through FMEA ... - 2020 Feb 25

Billerica, MA
... Played a vital communication role in assisting all teams within the department to ensure timely FDA submissions. Welcoming all guests and or candidates. EXPERIENCE 2005 – 2007 LINBECK GROUP, DESIGN AND CONSTRUCTION FIRM EXECUTIVE ASSISTANT Served as ... - 2020 Jan 26

Littleton, MA
... Conducted Phase I/II H5N1 vaccine clinical trial and analyzed vaccine elicited T cell responses from PBMCs isolated from participants Filed IND applications with Health Canada, the FDA and the EMA and we have had pre-IND meetings with each ... - 2020 Jan 21

Westford, MA, 01886
... Followed the corporate master brand guidelines, work instructions, SOP/SAP, and FDA specifications, while collaborating with teams consisting of legal, regulatory, quality, marketing, packaging engineering, manufacturing, and R&D. Managed multiple ... - 2020 Jan 02

Chelmsford, MA
... Non-normal data oSample size selection oStatistical process control techniques FDA 13485 2016 trained (Stat-O-Matrix) Edmund Foley Page 2 Smith-Nephew Lean Sigma Master Blackbelt (09/15 to 01/17) Provide Lean and Six Sigma training globally for SN. ... - 2019 Dec 16

Clinton, MA, 01510
... •Supervised construction of clean rooms and process areas for conformance to FDA regulations. •Managed an $8 Million operating budget and a $500K capital improvement budget. •Restored all landscaping, site utilities and mechanical systems for this ... - 2019 Oct 22

Acton, MA
... cause identification and action planning Performed quality system assessments to identify gaps in procedures and regulations (FDA 21CFR, ISO 13485) Conducted PFMEA to understand failure modes of the X-Ray systems Research Intern June - July 2012 ... - 2019 Aug 19

Worcester, MA
... Support the testing and development of new products with partners in Africa Key Accomplishments: - Managed 3 international FDA 510k sites and beta test sites in South Africa, Botswana, and Cote d’Ivoire to generate clinical data used for FDA ... - 2019 Aug 15