Date: May 7, 2025 Employment Schedule: Location:
Aalst, BE, 9320 Grosspostwitz, DE, 2692
Regulatory Affairs Manager - Class II (m/f/d)
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 in about 100 countries through leading retailers and healthcare providers. Ontex was founded in Belgium in 1979 and is listed on Euronext Brussels.
To reinforce our Quality team we are looking for a Regulatory Affairs Manager - Class II (m/f/d).
Maintasks:
1. Regulatory Frameworks and Strategy: Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities Monitor and evaluate the regulatory environment and provide creative and innovative internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance Identifies the need for new regulatory procedures and SOPs and assures that departmental SOPs are developed to ensure regulatory compliance and participate in development and implementation Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Identifies requirements and potential obstacles for market access and distribution (federal, provincial/territorial state, reimbursement, purchasing groups, HTA, etc.) and the need for further regulatory guidance Assists in the development of regulatory strategy and updates product strategy across internal teams based upon regulatory changes.
2. Product Development and Registration: Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing and offered plans/strategies (if appropriate) for changes that do not require submissions. Assembles, maintains or coordinate regulatory files to support product submissions Advises stakeholders of regulatory requirements for quality, preclinical and clinical data to meet applicable regulations. Monitors the progress of the regulatory authority review process through appropriate communication with the regulatory authorities. Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
3. Postapproval/Postmarket: Provides regulatory input and support and, as necessary, follow-up for inspections and audits. Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and instructions for use to reflect the current state of product knowledge. Responsible to ensure regulatory compliance with annual licenses, registrations and listings. Assures postmarket regulatory requirements are met (e.g., required reports, maintains files on annual licenses, registrations and listings and other postmarketing commitments).
Profile:
4. Master’s degree (university or equal through experience) in science
5. Minimum of 5 years experience in Regulatory Affairs for medical devices
6. In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
7. Knowledge of medical device regulations in other regions is an asset
8. Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971, …
9. Certifications in regulatory affairs like RAC are an asset
10. Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
11. Fluent in English and any other language is considered an asset (preferred German)
12. Experience in working with cross-functional teams and building strong relationships across departments
13. Ability to integrate and demonstrate core values, integrity and accountability throughout the organisation and externally
14. Ability to lead, manage, collaborate and communicate within the organisation, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession
We offer
15. Exciting and challenging projects with an international scope
16. A unique environment where local and international talents work and win together