Staff Specialist, Regulatory Affairs

🔥 2 minutes ago

🇨🇦 Canada – Remote

💵 $85k - $135k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 0%

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BD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $24M Grant on 2020-07

Healthcare • Manufacturing • Healthcare Insurance

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

📋 Description

• 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