SG
Scania GroupCompliance Officer
Compliance Officer supporting implementation of compliance frameworks in TRATON Financial Services. Collaborating across departments and focusing on AML and GDPR compliance in Romanian and Bulgarian markets.
About the role
- Serve as GRA Device Lead on assigned project teams
- Provide regulatory guidance and advice to Global Regulatory Team and cross-functional teams
- Develop and execute innovative and sustainable medical device regulatory strategies
- Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
- Liaise with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes
- Prepare, review, and approve design control deliverables
- Ensure appropriate communication, resolution, and/or escalation of issues
Requirements
- 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience
- 5+ years of medical device and/or combination product regulatory experience
- Experience in large organizations
- Familiarity with international submissions from within a global healthcare organization
- Bachelor's degree in a scientific or engineering discipline; graduate degree preferred
- Strong written and verbal communication skills, fluent in English
- Ability to manage multiple projects in a fast-paced, hybrid work environment
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Remote work options
- At least 14 weeks gender-neutral parental leave
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