Staff Specialist, Regulatory Affairs (16 month contract)

BD; Mississauga; On-site; CAD 85,000 - 135,000; Full time

Job summary

BD is seeking a Staff Specialist, Regulatory Affairs, to support MMS Dispensing products globally from a regulatory perspective. You will develop and execute global regulatory strategies for new products, sustaining, and end-of-life activities, including SaMD considerations.

You will monitor regulatory requirements, lead compliance with FDA, EU-MDR, and other regulations, and mentor regulatory talent. Strong collaboration with cross-functional teams and a results-driven mindset are essential for

Qualifications

• 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
• 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.

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 elevate 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

Job description

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

The 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 elevate 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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

CAN Mississauga - Derry Road West