Principal Specialist, Regulatory Affairs

San Gwann, MTFull-time€37k2026-10-23 → 2026-11-09

Core

Create strategy for Global Regulatory Affairs procedures, ensure compliance, lead RA systems (PromoMats, RIM), and establish data governance.

Role type

Principal Specialist, Regulatory Affairs (Systems & Process)

Builds

Global Regulatory Affairs procedures, processes, and data governance frameworks

Domain

MedTech / Pharmaceutical Regulatory Affairs

Deliverable

dashboards & analysis

Required skills

Regulatory strategy, compliance metrics, system upgrades, data governance, UAT test scripts, regulatory requirements evaluation, project leadership, data accuracy maintenance

Preferred skills

RIM system experience, Veeva Systems, SharePoint 2010, Excel, MedTech/pharma industry background

Technologies

RIM, PromoMats, SharePoint 2010, Veeva Systems, Excel

Responsibilities

Create strategy to identify changes to procedures/processes across Global Regulatory Affairs, Provide metrics to ensure compliance to requirements, Lead and support PromoMats, RIM and other RA systems, Participate in system upgrades to assure integrity of data is maintained, Verify the maintenance of support systems, libraries, and dictionaries, Maintain awareness of regulatory requirements and evaluate potential impact to Baxter, Responsible for establishing data Governance for RA systems

Seniority

Principal, hands-on IC

About Baxter

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.