Ontex is a leading international provider of disposable personal hygiene solutions for all generations. With a global team of around 7,500 employees, we develop, produce, and distribute products in about 100 countries through leading retailers and healthcare providers. Founded in Belgium in 1979, Ontex is listed on Euronext Brussels.
To reinforce our Quality team, we are looking for a Regulatory Affairs Manager - Class II (m/f/d).
Main tasks:
1. Regulatory Frameworks and Strategy:
o Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways, and compliance activities.
o Monitors and evaluates the regulatory environment, providing innovative internal advice throughout the product lifecycle to ensure compliance.
o Identifies the need for new regulatory procedures and SOPs, and ensures their development and implementation.
o Trains stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
o Identifies requirements and obstacles for market access and distribution, and the need for further regulatory guidance.
o Assists in developing regulatory strategies and updates product strategies based on regulatory changes.
1. Product Development and Registration:
o Evaluates preclinical, clinical, and manufacturing documents for regulatory filing and plans strategies for changes.
o Assembles and maintains regulatory files to support product submissions.
o Advises stakeholders on regulatory requirements for data to meet regulations.
o Monitors the review process with regulatory authorities.
o Communicates with regulatory authorities during development and review processes.
1. Post-approval/Post-market:
o Supports inspections and audits with regulatory input.
o Submits changes and updates to regulatory authorities.
o Ensures compliance with licenses, registrations, and listings.
o Maintains postmarket regulatory requirements and commitments.
Profile:
* Master’s degree in science or equivalent experience.
* Minimum 5 years in Regulatory Affairs for medical devices.
* Deep knowledge of US and Canada regulations for medical devices.
* Knowledge of regulations in other regions is a plus.
* Familiarity with quality management systems and standards like ISO 13485, ISO 14971.
* Regulatory certifications like RAC are advantageous.
* Interest or experience in Software as Medical Device (SAMD).
* Fluent in English; additional languages (e.g., German) are a plus.
* Experience working with cross-functional teams and building relationships.
* Demonstrates integrity, accountability, and leadership qualities.
We offer:
* Exciting international projects.
* A collaborative environment with local and international talents.
Visit us at ontex.com
Interested in a job at Ontex or need more information? Contact our HR team at jobs.grosspostwitz@ontexglobal.com.
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