Job ID: JOB_ID_1932
Position Summary
We are looking for a dedicated Regulatory Engineer / Regulatory Specialist to join our global medical device compliance team. This role is pivotal in managing product registration activities across diverse international markets, including APAC, LATAM, EMEA, Canada, China, Russia, and Japan. The successful candidate will ensure that our life-saving medical technologies meet the stringent requirements of global health authorities, facilitating timely market access and maintaining compliance throughout the product lifecycle.
Core Responsibilities
- Execute and manage product registration strategies for global markets, ensuring all submissions are accurate and timely.
- Prepare and review technical documentation, including STED (Summary Technical Documentation) and EU MDD/MDR technical files.
- Coordinate with Notified Bodies and international regulatory authorities such as Health Canada, TGA, NMPA, and ANVISA.
- Monitor global regulatory intelligence to identify changes in requirements and assess their impact on existing product portfolios.
- Maintain regulatory information systems (RIM) to track submission statuses, license renewals, and communication logs.
- Support the development and optimization of internal regulatory affairs (RA) systems and standard operating procedures (SOPs).
- Conduct gap analyses for EU MDR transitions and support the preparation of Design Dossiers for Class IIB and Class III devices.
Required Qualifications
- 2-3 years of experience for the Specialist level; 3-7 years for the Senior Specialist level.
- Mandatory experience within the Medical Device industry.
- Proven track record in global regulatory submissions and medical device registrations.
- In-depth knowledge of EU MDR/MDD requirements and CE marking processes.
- Familiarity with electromechanical devices and/or Class III implants is highly preferred.
- Strong research skills regarding country-specific approval pathways and regulatory standards (IEC, ISO).
Industry Outlook and 2026 Regulatory Landscape
As we move through 2026, the medical device industry faces an increasingly complex web of global regulations. The transition to EU MDR has set a high bar for clinical evidence and technical documentation, while emerging markets in APAC and LATAM are harmonizing their standards with international benchmarks. This role offers a unique opportunity to navigate these challenges at a global scale. Whether based in Pittsburgh, Bothell, or working remotely, you will be part of a high-impact team that bridges the gap between engineering innovation and patient safety. The demand for regulatory professionals who can manage the intersection of technical engineering and legal compliance has never been higher. We value candidates who bring a proactive approach to regulatory watch activities and who can effectively communicate complex requirements to cross-functional stakeholders in R&D, Quality, and Marketing.
Special Requirements
Remote work option available with travel to site as needed; Medical Device industry experience is mandatory.
Compensation & Location
Salary: $110,000 – $165,000 per year (Estimated)
Location: Pittsburgh, PA
Recruiter / Company – Contact Information
Recruiter / Employer: Diksha Technologies
Email: john.wilson@dikshatech.com
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