Regulatory Affairs Associate

Job title:

Regulatory Affairs Associate

Company:

IBA Worldwide

Job description

MissionYou will report to the Regulatory Affairs Director within Ion Beam Application SA Company.
He/she will perform and manage regulatory activities within a highly regulated, fast-paced industry to ensure that Company objectives are achieved in compliance with regulatory requirements. He/she will be in charge for managing all RA aspects associated with the development of new product projects and for communication with competent authorities according to the geographical area responsibilities.Challenges we trust you with

• Manage simple to moderate complexity regulatory projects:

• Ensure consolidated technical files meet the regulatory requirements and are kept up to date.
• Compile and submit simple/moderate regulatory submissions to regulatory authorities and notified bodies.
• Coordinate the preparation and the delivery of reviewing responses to regulatory authorities and notified bodies. Maintain registration information (license numbers, certification declaration, etc) and obtain re-registration approvals in advance of license/certification expirations.
• Identify laws, regulations, standards and guidance applicable to the organization in the target markets as defined by the management and according to the product specificities.
• Ensure regulatory compliance with applicable standards, directives and regulations.
• Identify deliverable documents required for market registration and conduct pre-survey reviews of these deliverables.
• Work proactively and closely with cross-functional teams on new product/feature launches according target market requirements. Provide guidance to the same.
• Assist RA management with activities related to regulatory inspections. Fulfill requests from other departments related to regulatory information and documentation

What we valueYou have:

• University Degree
• A minimum of 2 years of experience in medical device environment and regulatory affairs
• ISO13485 experience
• High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat, etc.
• Adaptable and willing to take on multiple new tasks and responsibilities
• Process oriented, logical, analytical, meticulous, highly organized and able to analyze data & implement solutions
• Willingness to travel
• Fluent in English and good writing skills

Life at IBAIBA GroupIBA is offering a broad and amazing diversity of careers. For our business units to perform at their best, they can rely on various shared services that give the appropriate support to each activities so that they can run their business smoothly. Finance, legal, corporate communication, human resources play together a key role in the company growth.IBA: Protect, Enhance and Save LivesIBA is the world leader in particle accelerator technology and designs, produces and markets innovative solutions for the diagnosis and treatment of cancer and other serious illnesses, and for industrial applications such as the sterilization of medical devices.IBA is driven by a mission to Protect, Enhance and Save Lives. IBA’s innovative mindset, dedication to technological and scientific progress and long-standing open relationships with customers and partners make IBA a unique scientific company.A committed companyIBA believes in a business model that creates shared and long-term value for all its stakeholders:IBA increases market share and return for its shareholders, improves quality of life for its customers, patients and employees, and contributes to the well-being of the society. All while maintaining and restoring the planet’s health. IBA has integrated this stakeholder approach into its company bylaws.This vision is operationalized since 2021 by the B-Corp certification, a holistic tool to assess, benchmark and ultimately improve its sustainability journey.Learn more about IBA and its technologies, download our new corporate brochure or visit

Expected salary

Location

Louvain-la-Neuve, Brabant Wallon

Job date

Thu, 16 May 2024 01:04:42 GMT

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