Senior Manager, Risk Management
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Position Description
Reporting to the Director of Regulatory Intelligence and Compliance, this position will plan and ensure the implementation of the ISO 14971, IEC 62366 and 21 CFR 820 standards to ensure safe products exceed customer and market requirements. This individual will need to work closely with manufacturing sites, support audits, work with new product development, as well as on-market teams in regards to change management and product life-cycle management. The Risk Management Engineer will ensure product development utilizes appropriate engineering and scientific analyses during the product development and commercialization process for medical device and combination products. In addition, conduct analysis and investigation of product or quality system issues intended to support the continuous improvement surrounding the quality of products and systems.
These include Allergan wholly owned facilities and third party contractors, and service/supply vendors. Responsibilities are for the medical devices and combination products both above plant and third party oversight. Standards and regulatory requirements are an evolving process, particularly in the major markets served. The corporate medical device/combo product risk management engineering function supplies information for product registrations and assures that all Allergan products comply with the appropriate regulations and Allergan requirements.
Main Areas of Responsibility
Develop and maintain Risk Management Files according to ISO 14971 and ensure Risk Management Files are updated per defined schedules and frequencies. This would include risk management plans, hazard analyses, user risk assessments, design risk assessments and process risk assessments. Provide Risk Management technical expertise through the product life cycle and drive the concept of Systems Risk Analysis across the organization.
Work with all production and post-production functions (manufacturing, post market surveillance, complaints, CAPA, Corrections and Removals, Change Control, Supplier Quality, acceptance activities) to ensure the proper application, use and updates of risk management files.
Support the Risk Management and Safety Management Team Review process to ensure all activities are completed to maintain the risk management file as new information is learned during the product development process or per signals obtained through post market surveillance programs.
Work with R&D, Medical Safety, CMC, Clinical Development on the development and incorporation of Risk Management during all design phases for new and/or product enhancements. Facilitate development and completion of risk assessments. Work cross-functionally with personnel and support the ongoing maintenance of appropriate harm/hazard analysis for issues potentially impacting patient outcomes.
Keep up to date on new regulations and standards that affect Risk Management for medical devices. Ensure Risk Management procedures, processes and files are updated where required. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams. Participate in regulatory inspection and notified body audits.
Supports developing department budgets, strategies and quality goal planning
Supports hiring, training and development of addition department staff.
Develop and maintain effective relationships and integration activities with other departments.
Requirements
The following listed requirements need to be met at a minimum level to be considered for the job:
Education and Experience:
Bachelor’s degree in engineering, physical or life sciences with a minimum of 7-10 years’ experience in the medical device quality engineering for new product development and sustaining product engineering.
Proven experience working with medical device companies’ Risk Management, Design Control and Human Factors Usability Engineering programs and/or processes
Experience with problem solving/risk assessment.
Proven ability to generate results.
Preferred Skills/Qualification
The below skills are attributes that may not be mandatory, but are definitely desired in the ideal candidate.
Excellent written and verbal communication skills.
Experience reading drawings, shop orders, and documentation.
Computer literate; use of word processing, spreadsheets.
Experience with statistical and six sigma methods required, and Black Belt
Experience with risk management processes and tools
Experience with sustaining engineering
Experience with Class II or III medical devices required, and experience with implantable devices preferred
Experience working with external contract partners for design, development, manufacturing, and/or testing
Extensive knowledge of US and International Design Control, Producte Development, Quality System and Risk Management requirements (specifically 21 CFR Parts 4, 803, 806, & 820, MDD, CMDR, ISO 13485, ISO 14971, EN 60601, IEC 62366 ), as well as other applicable standards (e.g., AAMI, ANSI) required
Critical Thinking and Problem Solving.
Ability to recognize problems and take corrective measures.
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