Compliance

• Draft cover letters and support the preparation of various applications ie: IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions
• Ensure protocols are in alignment with regulatory requirements and provide advise on required documents and submission strategies in preparation for those filings.
• Provide regulatory support throughout registration process
• Advise team on required documents and submission strategies in preparation of NDA, MAA as assigned (in collaboration with LOCs as appropriate)
• Assist with timely NDA, MAA availability, ensure that all document components are in place on time, identify and track critical path activities
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other)
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
• Assist in the preparation of meetings with Regulatory Agencies.
• Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high quality and timely responses.
• Act as back up contact/representative on specific multi-discipline teams, or with regulatory agencies as needed.
• May be responsible for organizing and leading meetings.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
• Support GRL(GRT) by driving high project management planning of global submissions or Health authority interactions and additional major regulatory milestones.
• Participate in global regulatory team meetings as appropriate
• Assist in strategy development by researching regulatory and medical information in preparing submissions to Global Health Authorities (HAs).

Manager, Global Regulatory Scientist – Regulatory Affairs

• Ensure the timely registration and market access of medical devices across the MSM region in compliance with applicable European, FDA, national, and regional regulatory requirements.
• Provide strategic regulatory leadership and partner closely with business stakeholders.
• Lead regulatory affairs activities across the MSM region to support business growth and market access objectives.
• Drive regulatory shaping and outreach initiatives through engagement with Health Authorities, regulatory agencies, and industry trade associations.
• Assess and communicate the impact of changing regulatory requirements on products, registrations, licenses, and business operations.
• Act as Regulatory Affairs Lead on cross-functional projects and regulatory initiatives.
• Ensure compliance of the medical device portfolio with applicable regulatory requirements and company policies.
• Lead continuous improvement initiatives to strengthen regulatory processes and operational excellence.
• Ensure audit and inspection readiness and represent Regulatory Affairs during internal audits and Health Authority inspections.
• Communicate regulatory compliance updates, risks, and recommendations to leadership and key stakeholders.
• Oversee the Copy Review process and support compliant promotional and non-promotional communications.
• Lead, coach, and develop direct reports while fostering a high-performing and collaborative team environment.
• Identify opportunities for process optimization and cost efficiencies.
• Ensure compliance with all applicable quality, legal, ethical, and Healthcare Compliance (HCC) requirements.

Associate Director, Regulatory Affairs, Electrophysiology

• U helpt ervoor te zorgen dat import- en exportactiviteiten voldoen aan de geldende douanevoorschriften, exportcontroles, sancties en handelsregelgeving.
• U doet onderzoek naar lokale wetten, regelgeving, procedures en handelsvoordelen, en vat vervolgens de belangrijkste wijzigingen samen voor interne belanghebbenden.
• U houdt toezicht op de import- en exportactiviteiten binnen de toegewezen bedrijfsonderdelen en regio’s om risico’s, limieten, beperkingen of nalevingskwesties te signaleren.
• U verzamelt, beheert en analyseert handelsgegevens, waaronder classificatiegegevens, ter ondersteuning van nauwkeurige rapportage en besluitvorming.
• U stelt documentatie voor import-/exportvergunningen op, stelt deze op en dient deze in, en volgt de goedkeuringen via de juiste overheidskanalen.
• U werkt samen met makelaars, leveranciers, contactpersonen bij de overheid en interne teams om ervoor te zorgen dat de documentatie volledig, nauwkeurig en conform is.
• U ondersteunt exportcontroleprocessen, waaronder screening van partijen met beperkingen, vereisten voor beveiligde servers, vergunningverlening, classificatie en beoordelingscontroles.
• U draagt bij aan procesverbeteringen, statistieken, audits en trainingen die de naleving van handelsregels versterken en bedrijfsrisico's verminderen.

Trade Compliance Analyst

• Management of local (BeNeLux) regulatory activities to obtain marketing authorizations for pharmaceutical products
• Management and/or support of activities as Responsible for Information and Publicity (RIP)
• Management of local (BeNeLux) pharmacovigilance activities including input to safety reports and management of ICSR as local QPPV
• Contribution to reimbursement files by medical writing and/or budget impact analysis and RWE collection.
• Contribution to Medical Affairs projects such as development of patient journeys, slide decks for training, patient, HCP and marketing materials.
• Management of stakeholder interactions including advisory boards and scientific presentations.
• Involvement in medical information activities at local and global level. This entails replying to medical enquiries and relevant reporting of adverse events, technical complaints or special situations.
• Management of field market access research.

Compliance jobs in Belgium

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Manager, Global Regulatory Scientist – Regulatory Affairs

Associate Director, Regulatory Affairs, Electrophysiology

Trade Compliance Analyst

Regulatory Affairs Manager