Job DescriptionThe Staff Specialist of Regulatory Affairs reports directly to the Senior Manager of Regulatory Affairs. This position is responsible for supporting MMS Dispensing products consisting of non-Medical and Medical Devices and associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of developing and executing global regulatory strategy to support new product development, sustaining, and end of life activities.
Key responsibilities:- Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW
- Lead regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, 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
- Develop and implement global regulatory strategy for MMS Dispensing products and software
- Assure that QSMR requirements are followed and executed consistently from RA perspective
- Execute Technical File creation and remediation, collaborating with cross-functional teams for required content
- Draft and execute comprehensive regulatory impact assessments for design control changes to existing products
- Performs other duties and assignments as required
Education & Experience :- Bachelor's degree in biology, engineering, or other science related discipline required. Advanced degree (e.g. MS, PhD) preferred
- 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 and Skills:- Regulatory and Quality Information Management systems such as SAP, RIM, or related systems
- Digital literacy MS Word, Excel, PowerPoint, Teams
- Project Management experience
- Excellent verbal and written communication skills, with strong attention to detail
- Strong organizational, project, and submission management skills, with the ability to prioritize multiple activities and meet competing deadlines
- Strong collaboration and teamwork skills, with the 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 and continuously learn
- Results-driven, with strong functional and technical knowledge and a demonstrated ability to achieve goals successfully.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Your Career at BD".
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors that contribute to the range displayed. The range displayed is comprised of wages, which includes base salary and commission, as well as certain components of our bonus programs. The salary offered to a successful candidate may vary based on a variety of factors including relevant experience, education, skills, qualifications, and work location.
Salary Range Information: $85000 - $135000 CAD Annual
This job posting is for an existing vacancy
As part of our recruitment process, we may, in certain circumstances, use technologies such as artificial intelligence or machine learning to screen, assess, or select applicants. These technologies will only be used in accordance with applicable laws and regulations.
Primary Work LocationCAN Mississauga - Derry Road West
Additional LocationsWork Shift 
