Global Head of Compliance responsible for building and leading compliance functions at OpenFX. Overseeing regulatory compliance and financial crime prevention in a fast - growing fintech firm.
About the role
- Senior Regulatory Affairs Specialist collaborating with cross-functional teams on regulatory strategy for medical device products at Siemens Healthineers. Ensuring compliance with global regulatory requirements and supporting product development efforts.
Responsibilities
- Serve as a regulatory partner to R&D, Quality, Clinical, Manufacturing, Operations, and Marketing teams across NPI and sustaining activities
- Independently assess regulatory impact for new products and changes, and provide clear regulatory pathway recommendations
- Develop and maintain regulatory strategies aligned with business priorities and evolving regulatory requirements
- Interpret and apply applicable regulations, standards, and guidance (e.g., FDA, EU MDR, Health Canada and ROW) and translate them into practical development guidance
- Review and approve R&D, quality, preclinical, and clinical documentation for regulatory submissions
- Compile, prepare, review, and submit high-quality regulatory submissions in the U.S., EU, and Canada; support international filings as needed
- Support regulatory authority interactions by drafting briefing materials, responses, and correspondence
- Prepare and maintain licenses, registrations, and listings for assigned geographies
- Support product safety reporting (e.g., MDR, Vigilance), recalls, audits, and regulatory inspections
- Maintain regulatory files, systems, and tracking databases
- Identify emerging regulatory issues and proactively provide guidance to functional teams
- Exercise sound, ethical judgment in compliance with regulations and company policy
- Manage multiple priorities concurrently with accuracy and accountability
Requirements
- 7+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices
- Demonstrated experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers
- Experience in the use of clinical data to support regulatory submissions (e.g. expansion of indications)
- Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus
- Strong ability to interpret regulations, identify regulatory data needs, and solve regulatory issues
- Ability to balance detailed execution with broader regulatory strategy development
- Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993
- Educational background: Bachelor’s degree Engineering/ Life Sciences (advanced degree preferred)
- RAC certification (U.S. or EU) is a plus
- Strong judgment and comfort making regulatory recommendations under uncertainty
- Clear, concise verbal and written communication skills across diverse audiences
- Highly organized with strong prioritization and project management skills
- Proficiency in MS Word, Excel, PowerPoint, and Adobe
Benefits
- medical insurance
- dental insurance
- vision insurance
- 401(k) retirement plan
- life insurance
- long-term and short-term disability insurance
- paid parking/public transportation
- paid time off
- paid sick and safe time
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