Job Description

Position Summary:

The role of Senior Manager, Market Quality Assurance and Regulatory Affairs will promote create/improve standards of quality within the designated region(s) by influencing and managing all quality related activities. This role will work closely with Market Quality and Regulatory Affairs Director to develop and implement Quality strategy and provide strategic leadership to the designated region(s). The individual will interact with and provide oversight to local operating companies to ensure adherence to the ASP quality management system and local/in country regulations.

Duties and Responsibilities:

Under limited supervision, general direction, etc. and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position: Develop, own and drive new business strategies across SEA, Australia, New Zealand and India that lead to business growth.

• Implements and oversees the ASP Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance for SEA, ANZ & India.
• Assures compliance with applicable local regulations such as, but not limited to, FDA 21 CFR 820, ISO13485, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA.
• Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics for SEA, ANZ & India.
• Responsible for or together with QA personnel be involved in processes such as maintenance of distribution records, complaint handling, maintenance and service agreements, field actions, AE reporting, and reporting changes to TGA & Medsafe, NCC (National Communication Committee), etc.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance for SEA, ANZ & India.
• Participates and hosts internal and external audits for ANZ & India. May serve as liaison between local health authority and the business for SEA, ANZ & India.
• Maintains a comprehensive audit readiness program to ensure internal and external quality compliance for SEA, ANZ & India.
• Maintains knowledge of regulatory changes through regulatory standard management process and close cooperation with regulatory affairs for SEA, ANZ & India.
• Establish local and regional relationships with regulatory affairs, commercial, and logistics team for SEA, ANZ & India.
• Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring) for SEA, ANZ & India.
• Maintains quality oversight of any local required establishment licenses, or QMS certifications for SEA, ANZ & India.
• Maintains local supplier/vendor selection, qualification, and audits for SEA, ANZ & India.
• Maintains quality records and adherence to records retention policies and procedures for SEA, ANZ & India.
• Maintains quality oversight of field service processes/procedures for SEA, ANZ & India.
• Maintains quality training program with respect to quality system elements for SEA, ANZ & India.
• Establish corrective and preventive actions to mitigate potential or actual noncompliance risks for SEA, ANZ & India.
• Assesses product quality issues and escalates to upper management through established processes for SEA, ANZ & India.
• Ensures timely post-market surveillance & vigilance (Field Actions and Product Complaints) management for SEA, ANZ & India.
• Responsible for communicating business related issues or opportunities to next management level for SEA, ANZ & India.
• Performs other duties assigned as needed
• Set up short-term and long-term regulatory strategy and efficiently implement the strategies to ensure successful market access of new products, transitioning/ maintaining/ updating the existing licenses/approvals, and regulatory compliance for SEA, ANZ & India.
• Establish and implement SEA, ANZ & India local procedures to ensure regulatory submissions, approvals are the most efficient per regulation requirements and international guidance where applicable.
• Support to develop, initiate, and revise procedures to regulatory affairs to ensure compliance to the medical device regulations and applicable products and company policy.
• Support the team to collect, monitor, analyze and interpret SEA, ANZ & India product relevant regulations, industrial standards, national standards professionally.
• Provide regulatory support to and communicate with internal stakeholders for business growth of assigned projects for SEA, ANZ & India.
• Support to audit, post market surveillance activities from regulatory perspective.
• Monitor new and revised SEA, ANZ & India regulatory requirements, proactively influences local authorities (inclusive of but not limited to local healthcare authorities, etc.) on relevant regulations, guidance, and standards, timely analyze and communicate new/changes of the requirements

where applicable, and support to translate regulatory requirements into practical, workable plans for SEA, ANZ & India * Provide timely regulatory assessment and actions based on the notice from global regulatory affairs team for SEA, ANZ & India

• Represent the company to interact with regulatory bodies as appropriate; may direct interaction with regulatory agencies on defined matters for SEA, ANZ & India.
• Provide other necessary regulatory support to internal departments for SEA, ANZ & India

Qualifications:

Bachelor\'s Degree

Years of Related Experience:
At least 5 years\xe2\x80\x99 experience in the Medical Device industry
Regulatory Affairs Certification (RAC) and/or Certification in Medical Device Regulatory Affairs preferred

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:

Demonstrated knowledge of the local regulatory standards and regulations, FDA 21 CFR 820, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA, ISO 13485, ISO 9001, ISO 14971.
Ability to effectively negotiate and influence above, below and across the organization
Ability to work and communicate in a cross-cultural environment.
Excellent communication skills both written and verbal
Highly developed influence, interpersonal, communication and conflict resolution skills
Ability to interact with all levels and disciplines within the organization
Must be able to work on multiple priorities and tasks simultaneously, while acting in a decisive manner and demonstrating a bias for action
High sense of urgency, adaptable to meet rapidly changing priorities
Proven analytical/quantitative skills
Project management skills, with the ability to drive change and influence decision making through multiple levels.
Fluency in business English, orally and in writing

Fortive Corporation Overview

Fortive\xe2\x80\x99s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We\xe2\x80\x99re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential\xe2\x80\x94your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We\xe2\x80\x99re honest about what\xe2\x80\x99s working and what isn\xe2\x80\x99t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

Ready to move your career forward? Find out more at .

Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.

Fortive