Regulatory Affairs Specialist (Pre-Market and Post-Market)

The Role

Sinclair is currently looking for a Pre-Market and Post-Market Regulatory Affairs Specialist based in Israel.

Working within the Corporate Regulatory Affairs Team, the Pre-Market and Post-Market Regulatory Affairs Specialist ensures regulatory requirements are met for new product development and design changes to established legacy devices.

Reporting to the Team Leader Registration and Regulatory Affairs Engineer, the position holder assures the design and development processes contain the correct regulatory requirements and supporting evidence. Working closely with Research and Development and other business departments, the position holder will also ensure the type of testing certification such as electrical compatibility and compliance to product-specific standards and directives. This assures the integrity of the design history file and technical documentation as a precursor to country-specific registration(s).

This position provides and contributes to the Regulatory deliverables from internal Research and Development projects, contributing to providing Regulatory solutions to business requirements and changes to the regulatory landscape. This position provides operational Regulatory input and guidance to cross-functional teams, ensuring compliance to the UK, European, USA, and International country-specific legislations.

This position will prepare dossiers and technical documentation for product submissions worldwide. This position will be responsible for the management of the submission with the regulatory agency.

About Sinclair

Founded in 1971, Sinclair is a global medical aesthetics organization, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.

This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.

Our Vision

Providing aesthetic excellence globally.

Our Mission

Driving the advancement of product quality and customer satisfaction, investing in innovation and people.

Our Values

Act with Integrity

Be results driven

Embrace your winning spirit

Stay ahead of the game

One team, one goal

Key Responsibilities:

• To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices, particularly in EU, US, UK, and Canadian territories
• Preparation of technical documentation and submission packages (STEDs) for the filing of premarket global regulatory submissions in line with company strategy
• Establish and maintain regulatory information systems, technical documentation files and routine reports
• Collaborate with global Regulatory Affairs teams to understand existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures
• Ensure regulatory compliance to global requirements and company policies
• Support new product development activities
• Review documents and product changes for regulatory submission impact
• To provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities
• Review and approve product artworks and relevant marketing materials according to Sinclair strategies and any applicable regulatory requirements or standard
• To identify, deliver and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs
• Liaise with and assist vigilance team and risk management team with respect to requirements of product dossiers and relevant post marketing activities as and where necessary
• Assist and support inspections and audits
• Liaise with, assist, and support in the creation of QMS process for regulatory aspects. Responsible for the local implementation and training of regulatory process
• Responsible for leading and monitoring the assigned registration processes in the countries of commercialization of the Company's medical devices
• Coordination and preparation of the documentation associated to the registers of medical devices to be delivered to the national or international Health Authorities.
• Administrative tasks and procedures in the different embassies and consulates for the legalization of the different documents necessary for the registration of the products in the different countries.
• Coordinate the signature of Quality and Release certificates of cosmetics and medical devices.
• Deputise for Manager as required.

Your Skills & Experience – Do You Have What it Takes?

Essential:

• Bachelor's degree in Electronic/Mechanical Engineering, Biomedical Engineering.
• Minimum 3 years experience in Regulatory Affairs (Pre-Market and Post-Market) within a Medical Devices organization.
• Mandatory RA experience with energy-based devices / active devices.
• Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC 62304)
• Experience with the Medical Device Regulation.
• Knowledge of other regulatory legislation and guidelines, e.g., US, and Canadian regulations.
• Excellent attention to detail when reviewing and preparing documentation.
• Organised, target-orientated, flexible, good time management skills.
• Strong written and oral communication skills.
• Excellent attention to detail when reviewing and preparing documentation.
• Fluency in written and spoken English.

A bit about you – do you fit this description?

• Personal responsibility.
• Able to work autonomously and proactively.
• Communication, impact and influence.
• Analytical and critical thinking capacity.
• Time management, organization and planning.
• Work accurately with attention to detail and promote quality culture through the business.
• Orientation towards achievement.
• Adaptability and openness to change.
• Ability to learn.
• Integrity and professional ethics.
• Cross-disciplinary cooperation.