Join our team as
Tenders & Regulatory Affairs Specialist
NLD-Nijmegen
Are you a detail-oriented professional with a talent for ensuring accuracy and regulatory compliance? Do you enjoy managing product documentation, handling tender support, and improving processes that directly impact customer and commercial efficiency? Are you looking for a new challenge in a fast-evolving healthcare environment?
Then you might be the perfect fit for our Tenders & Regulatory Affairs Specialist (50% part-time) role !
Based in our Nijmegen (Nl) office, this is a great opportunity for a motivated professional eager to drive streamlined regulatory processes and risk mitigation within our organization.

YOUR EXPERIENCE AND SKILLS:

To make this position a success, we are looking for someone who initially fulfils the function described above, who has interest in the culture of Paul Hartmann and shares its values.
In addition, we are looking for these experience and skills:
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- Bachelor’s degree in a relevant field (e.g., Marketing, Business, Regulatory Affairs) or equivalent practical experience.
- At least 3 years of experience in a similar position.
- Strong written & oral communication skills (Dutch English) French is an asset
- Strong data management skills.
- SAP HANA, PEGA, Hybris (PIM) is an asset.
- Result-driven and customer-focused.
- Flexible, energetic, and reliable, with a strong sense of initiative.
- Strong organizational and multitasking skills.
- Tender knowledge in the Netherlands.
- PEGA & Excel is an asset.
- Strong written customers communication (Dutch/English). French is an asset
- Cross-functional collaboration with internal teams (e.g. Tender department).
In order to test the suitability of the candidate, an assessment may be part of the procedure.

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• Ensure accurate product documentation and regulatory compliance.

• Manage product certificates, Technical Data Sheets, and web shop content.
• Handle Complaint management B2B & B2C: registration of quality and safety complaints, communication and follow-up on handling of complaints, communication with customer (SAP HANA from introduction to proposal of customer letter).
• Analyses of complaints.
• Support product recalls, FSN, FSCA
• Manage Z-Index requirements.
• Support tender documentation and coordination.
• Follow up and review tender calendar.
• Data & Product Information Management.
• Collecting central data & updating in local digital platforms: webshop , PEGA.customer/product data , AIS price lists , HD/HA , Salesforce
• Maintain PIM system up to date with dual-lingual product info.
• Search and send various product certificates and pictures (DOC /CE / latex, etc.) and fill in product info excel for clients
• Answer to regulatory questions of customers and internal team (DoC, CE certificates, …).
• Update of Benelux SOP’s if needed.
• Release RA Regulatory Affairs tasks in PEGA.
• TDS translation (centralisation of request from internal departments, quote request to translation office, introduction of order in MyPurchase, reception of order and transmission to concerned department).
• Pack validations (NL (FR) from Corporate/BODE).