Sales Operations Coordinator
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POST DATE 12/14/2019
END DATE 12/24/2019
Stanley Black & Decker
JOB DESCRIPTION1Position Summary
Collaborates with R&D, Sustaining Engineering, and Quality to develop positive and proactive approaches to regulatory compliance, ensuring product and company compliance with global product standards and directives (UL, FDA, CE, EN and CSA, FCC etc.)
Essential Job Functions
* Ensure product and company compliance with global product standards and directives (UL, FDA, CE, EN and CSA, FCC etc.)
* Coordinate product testing and safety agency testing including Software, Hardware, and product safety & associated markings
* Assist in identification & selection of new and alternate components.
* Participate in 3rd party agency audits.
* Evaluate and analyze 3rd party laboratories detailed test reports, and provide detailed test report improvement suggestions.
* Work closely with an independent test agency to carry out plans through completion including managing appropriate reports, notifications, product labeling, etc.
* Assist in maintaining product listings and establishment registrations with FDA;
* Create and maintain regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements
* Create processes to ensure the Compliance Team communicates policies and processes as it relates to regulatory compliance (FDA, FCC, CE, global)
* Initiate and manage international type approvals for wireless products
* Provide regulatory support to the Sustaining Engineering and R&D;
* Work with QA and Engineering in generating risk analysis, FMEA, and Risk Assessment activities such as Hazard Analysis.
* Submit document change orders (ECO/agile) for approvals;
* May represent Regulatory Affairs department in project meetings and provide regulatory guidance;
* Update RA responsible quality system procedures as required (SOP s);
* Support the regulatory team managing international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, technical files, STED Documents and related submissions;
* Performs other duties or special projects as assigned;
Education / Requisite Skills:
* B.S. degree in Science or Engineering disciplines (electrical, mechanical, chemical, industrial or a law degree)
* 2 5 years experience with standards conformance
* Professional certifications desired, e.g. CSP, CIH, PE
* M.S. degree or related level of experience a plus.
* Two to five years of work experience with standards conformance i.e. UL/ETL certification process required;
* Experience in Quality Systems per ISO 13485;
* Knowledge of Unique Device Identification (UDI) requirements desired
* Experience in patient monitor systems, hospital-based products, software or electronic device products desired;
* Experience with FDA/GMP requirements for medical device desired
* Experience interacting with regulatory bodies, such as the Notified Body;
* One to five years of work experience in a medical device Class I/ II environment desired;
* Computer Proficiency with MS Office (Word/Excel/Access/Outlook);
* Excellent verbal and written communication skills;
* Excellent prioritizing, organizational, and interpersonal skills;
* Excellent documentation skills including record maintenance/ tracking and understand document traceability;
* A detail-oriented individual with a can do attitude and ability to work in a team environment
* Ability to work in a fast-paced environment, with multiple tasks/projects;
All qualified applicants to Stanley Black & Decker will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, veteran's status, age, disability or any other characteristic protected by law