Senior Manager Regulatory Affairs

Healthcare Informatics/Patient Monitoring

•Reports directly to VP, GM of
Strong dotted line report to HI/PM Sr. Director, Quality and Regulatory
•Key member of business management team
•Functional responsibility for Q&R management at remote locations
•Direct management of local Q&R staff (8 ee’s)

•compliance, sustainability, product quality and proProvide management oversight and strategic direction for quality and regulatory activities within the business including: regulatory approvals, quality and environmental management systemcess improvement.
•Provide leadership, vision, coaching, mentoring for the business’ quality & regulatory organization
•Provide multi-site leadership to ensure the ongoing performance, safety and compliance of products and services
• Drive regulatory strategy within the business to meet product development and release schedules.
• Work closely with the cross-functional management team to develop and improve business results through processes to speed time to market without sacrificing quality or compliance.
•Provide leadership to all business locations to ensure product quality and quality system compliance to ISO 13485 and FDA Quality System Regulation (21 CFR 820), Environmental compliance to ISO 14001, Canadian CMDCAS, Japan PAL regulation and all other worldwide medical device quality and environmental regulations.
•Coordinate quality and regulatory activities between business lines to create a common quality and regulatory direction for the business.
•Identify and implement best practices between all locations to improve efficiency without risking compliance.
•Champion product quality improvement
•Provide regulatory information, opinion and interpretation to entire business.
•Manage FDA product submissions.
•Interface with FDA (or other regulatory agencies).
•Create a quality and regulatory community within the business.
•Participate in Quality Council, which sets quality policy and resolves systemic quality issues for entire business line.
•Conduct quality system management reviews.
•Develop and implement multi-site Q&R processes to improve business results by aligning with business strategic initiatives and priorities, while introducing flexibility and efficiency.
•This position is the authority in the Business regarding the following key issues and decisions:
Whether product can legally ship.

Whether product that has shipped to customers must be recalled for safety reasons or for violation of country law.
Reportability to worldwide regulatory/government agencies, and subsequent public disclosure, of device malfunction or serious injury or death.
Business risk and strategy surrounding acquisition or integrating another company or conducting business with a device OEM business partner
Most effective strategy for process harmonization and improvements to minimize product cost, increase business efficiency, improve financial results, and speed time to market
Criteria for placing device production on hold pending investigation of a potential safety issue or a legal violation (adulterated product)
Exclusion or inclusion of certain device features based on regulatory/legal risk and how device features may be advertised to the public to ensure legal compliance.

Bachelor’s degree in a technical discipline. An advanced degree in law or management is strongly preferred.
•Minimum 5-10 years of progressive management experience in a responsible quality assurance/regulatory affairs role in a software medical device environment.
•Expertise in FDA QSR, ISO13485 and European medical directives.
•Working knowledge of FDA regulations including 510(k) and MDR.
•Demonstrated ability to lead, communicate, interact and influence effectively at technical and management levels across functions, entities and external agencies.
•Proven leadership in formulating and implementing global strategies to ensure product quality, compliance with worldwide regulations, and timely product approvals to maximize business profit.

Proven track record of positive change management skills.