Compliance Officer executing Canadian FINTRAC/RPAA registrations and AML controls for Mercuryo’s crypto on/off - ramp and fiat remittance platform. Coordinating regulatory filings, investigations, testing, and cross - functional compliance projects.
About the role
- Regulatory Affairs Specialist supporting BD’s global medical device and software portfolio. Developing regulatory strategies, Technical Files, and compliance assessments for MMS Dispensing products.
Responsibilities
- Report directly to the Senior Manager of Regulatory Affairs
- Support MMS Dispensing products, including non-Medical and Medical Devices, associated Software, and Accessories, globally from a Regulatory Affairs standpoint
- Develop and execute global regulatory strategy for new product development, sustaining, and end-of-life activities
- Monitor and interpret current and new regulatory requirements and international standards for the U.S. and rest of world
- Lead regulatory efforts to comply with new and existing regulations, including FDA Medical Device Regulations and EU-MDR
- Problem-solve and escalate regulatory and compliance issues to senior management as necessary
- Provide effective communication and quick responses to internal customers
- Drive continuous improvement in internal processes and customer satisfaction
- Identify, develop, and mentor high-performing regulatory talent
- Assure QSMR requirements are followed and executed consistently from a Regulatory Affairs perspective
- Execute Technical File creation and remediation in collaboration with cross-functional teams
- Draft and execute comprehensive regulatory impact assessments for design-control changes to existing products
- Perform other duties and assignments as required
Requirements
- Bachelor’s degree in biology, engineering, or another science-related discipline required
- Minimum of 5–7 years of directly related Regulatory Affairs experience in medical devices required
- Focus on SaMD strongly preferred
- RAPS RAC certification preferred
- Knowledge of Regulatory and Quality Information Management systems such as SAP, RIM, or related systems
- Digital literacy in MS Word, Excel, PowerPoint, and Teams
- Project Management experience
- Excellent verbal and written communication skills, with strong attention to detail
- Strong organizational, project, and submission management skills
- Ability to prioritize multiple activities and meet competing deadlines
- Strong collaboration and teamwork skills
- Ability to lead and influence without direct authority
- Strong regulatory strategy development skills
- Flexible and adaptable, with the ability to respond effectively to changing business priorities
- Functional and technical knowledge with a demonstrated ability to achieve goals successfully
Benefits
- Comprehensive Total Rewards program
- Reward and recognition opportunities
- Competitive package of compensation and benefits programs
- Workplace accommodations considered pursuant to applicable law
- Remote work arrangement indicated for this position
- Flexible work-life balance recognized by the employer
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