Regulatory Affair Leader

PRIMARY FUNCTIONS

The Regulatory Affair Leader focus in this position is to manage and provide regulatory guidance, support and compliance with the all regions. In this role, the individual will be the recognized expert, managing projects or processes, with responsibilities that include working with cross-functional areas to identify, modify, or create necessary documentation to meet the global regulatory requirements and other country related documents.     

• Collaborate with RA Manager and RA team in Israel to develop and implement regulatory strategies for global registration.      
• Support the regional teams by working and alignment on Medical Device regulations and Standards.     
• Develop and be the interface between regional teams and the teams in Israel %28Regulatory Assurance %28RA%29 and Business Group%29 for new product development to ensure compliance to global regulations.     
• Collaborate with the internal team for post market activities if needed and to align with the intercompany activities     
• To ensure submissions meet regulatory requirements and maintain up-to-date knowledge of regulatory requirements.

ESSENTIAL DUTIES & RESPONSIBILITIES

·        Build and maintain a working familiarity and practical understanding of Global regulatory requirements, specifically US,EU, Japan, China, Korea, AUS, Canada, Brazil, Taiwan and Isreal.

·        Preparation, publication, quality control, and delivery of technical documentation required for full compliance any country required documents for regulatory submissions.

·        Update regulatory country database for product registrations.

·        Examines & strategizes with the local RA teams complex matters where analysis of situations or data requires an in-depth evaluation of multi-variate factors.

·        Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining timely & favorable results.

·        Assists operating areas in developing and revising affected policies and procedures to ensure compliance with applicable laws.

·        Engage collaboratively with project teams and regional specialists, which are comprised of personnel from regulatory, quality, clinical, R&D, and operation functions to ensure efficient execution of a shared strategy

·        Support, update and maintain design dossier/ product technical files/Technical Documentation, to ensure compliance and the timely and accurate filing of regulatory documentation.

·        Act as liaison with regulatory personnel to address questions and issues that arise as part of the registration process.

·        Develop a product regulatory timeline aligned to product development, with regulatory milestone, and activities for submission filing.

·        Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices

·        Knowledge of device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations.

REQUIREMENTS

·        Requires a bachelor’s degree or Advanced Degree in Science or Health Related Field

or Law degree with past knowledge in Science or Health Related Field.

·        Minimum of 3-4 years of experience in medical device sector and regulatory experience

·        Excellent organizational and multi-project management skills, with specific attention to detail.

·        Strong interpersonal skills with the ability to influence others in a positive and effective manner.

·        Proven mastery & demonstrated understanding of all regulatory affairs aspects related to medical devices.

·        Knowledge of relevant standards for electrical medical equipment

·        Regulatory experience in medical equipment companies and familiarity with FDA requirements, the requirements of European Directive and Canadian requirements

·        Working knowledge of international laws, regulations, and guidance that affect assigned devices specifically with respect to the EU Regions %28i.e. EU Medical Device Directive %28MDD%29 93/42/EEC, and CE mark process%29

·        Exposure to EU Medical Device Regulation %28EU MDR%29 2017/245.

·        Risk adverse where needed with the ability to identify potential solutions to complex problems

·        Demonstrated ability in analytical reasoning and critical thinking skills.

·        Knowledge of the quality process, including standards, methods, and procedures.

·        Experience with Class II/III medical devices.

·        Ability to work through others.

·        Strong computer skills and a high attention to detail.

·        Experience working in a medium size global company is preferred.

·        Be able to work in a matrix organization.

·        Fluent in English, Excellent expression skills – written and verbal.

·        Responsible, self-motivated, organized and meticulous.

·        Able to multitask and meet the targets set.