Job Description
Our Client:
Our client is leading Medical Device MNC with strong global presence. Leaders in the "Eye Care" industry with a very rich pipeline and wide spread of reputed brands.
The Responsibilities:
* The Head Global Regulatory Affairs will be responsible for end to end regulatory, licensing and registration activities in line with the respective country regulations
* Will directly involve in key stakeholders engagement and synergise not limited to Commercial, Operations, Technical and Manufacturing to support in claims review & approval, licensing, labelling, sales promotional material review, regulatory and incremental submissions based on operations and manufacturing transformation and changes. Have a solid understanding of 21CFR820 along with experience with FDA submissions including 510k, De Novo, as well as FDA pre-submissions
* Leads development of regulatory plans and clinical trial strategies
* Work closely with Marketing and R&D to set priorities and strategies to meet business needs
* Review and interpret regulatory rules and ensure that they are communicated to the cross functional teams and the business. Advises management on future International regulations, based upon thorough knowledge of applicable regulations for clinical studies and regulatory submissions
* Update the Master technical file database to support, create, and maintain US specific documents
* Develop and execute plans and timelines for approvals of products in new product pipeline
* Gets the balance right between strategic, tactical and operational support. Ensures that the team is perceived as being both subject matter experts and pragmatic business partners who help other teams to focus upon and prioritize the allocation of RAQA resources on the products that will provide the greatest long-term return on investment
* Provides training for all stakeholders on current and new regulatory requirements to ensure understanding and companywide Compliance
* Ensures product registration requirements, are understood by project teams, in order to create technical reports during development that will support global registrations
* Collaborates either directly with the Ministries of Health or through qualified consultants based in USA. This position needs a deep understanding of and experience in obtaining medical device registrations and/or licenses
* Leads, organizes, prepares and submits Notified Body applications and other regulatory documents and interfaces with the Notified Bodies on submissions for market approval
* Promotes standardization of submission formats and processes within the organization
* Partners with the Commercial teams to plan and support the regional Long-Range Strategic Plans (LRSPs)
* Is a strong leader for the RA and inspires and coaches the team with all people management related activities including recruitment to objective setting, performance appraisals, addressing training needs as well as creating a high performing and well-respected team)
* Receives timely product and/or marketing approvals
* Tracks and report status of approvals
* Manage the submission process by ensuring that planned regulatory submissions are progressing in a timely fashion
* Manage and report submission updates against milestones
* Identify areas of risk of jeopardizing the timeline
* Identify areas of resolution to timeline issues
The Requirements:
Role:
* Shall be responsible for development and synergising all regulatory requirements and will strategize, develop and implement defined/agreed strategies to support client's business plans
* Being key member of the client's Global Senior Leadership team, will ensures timely preparation of organized and scientifically valid submissions, provides expertise in translating regulatory requirements into practical, feasible plans and interacts with regulatory agencies, R&D, Marketing, supply chain, and the regional RA staff
* Lead and maintains departmental databases and filing systems for regulatory documentation
* Leads in the Design Control Cross functional teams
* Ensures compliance with all International regulatory requirements pertaining to conducting clinical trials, product approval, marketing, and labelling in submissions
* Excellent people and project management skills, with ability to prioritize and handle multiple projects at the same time
Experience:
* Strong knowledge of working in a Global environment along with hands-on exposure within international business, product knowledge, regulatory guidelines and required legal product registration processes
* Have a solid understanding of 21CFR820 along with experience with FDA submissions including 510k, De Novo, as well as FDA pre-submissions
* Have experience working with FDA to resolve feedback from the agency
* Skilled in conflict management, analytical, problem solving, stakeholder's engagement, effective communicator with executive presence & strong computer skills. problem solving ability, analytical and communication skills
* Minimum 10-12 years of experience in Medical Devices Regulatory Affairs (ISO 13485 certified) preferably in Optical/ Vision care industry.
* Required 6 years in a leadership role working across diverse countries, cultures and cross-functional collaboration
* Bachelor's Degree minimum. Optometry qualification desired but not mandatory
* Excellent communication skills
* Have experience working with FDA to resolve feedback from the agency
Disclaimer: The Company complies with the Tripartite Guidelines on Fair Employment Practices (TGFEP), including the prevailing guidelines on recruitment. All qualified applicants will be considered for the position regardless of their age, race, religion, nationality, marital status, or family responsibilities. A more detailed discussion of the TGFEP is available on the Tripartite Alliance for Fair and Progressive Employment Practices (TAFEP) website at https://www.tal.sg/tafep.