Senior Regulatory Affairs Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Markham, Ontario, Canada Job Description: About Orthopaedics: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech DePuy Synthes is recruiting for a Senior Specialist, Regulatory Affairs - MedTech, located in Toronto, Ontario. Purpose: Helps establish and implement compliance with regulatory agency regulations by providing advanced knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements. Analyzes and interprets scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market. You will be responsible for: Develop, lead and execute Canadian Regulatory strategies for complex Class III and Class IV medical devices, including combination products, to achieve and exceed business objectives. Manage all Regulatory aspects of the product lifecycle from pre-market to post-marketing phase including reviewing and approving promotional material in alignment with corporate and Health Canada requirements. Support internal and external audits for local and global business units Provide expert Regulatory guidance to internal stakeholders and mentor junior Regulatory Specialists and Associates to build team capability. Establish and maintain strong relationships with Health Canada and business partners, driving collaboration on submission strategies, Regulatory pathways, submission status updates, recalls, and special access processes. Maintains and continuously improves the Quality Management System (QMS) at DePuy Synthes in accordance with Health Canada regulations and corporate requirements, covering critical Regulatory and quality processes (i.e. distribution, supplier management, CAPA, change controls, document/records management complaint management and vigilance) to enhance efficiency, compliance and overall performance. Leads or contributes to both local and global strategic Regulatory or quality projects within the QMS and/or distribution workflows including process optimizations with a focus on digital and data-driven approaches Support preparation and execution of internal and external audits, including Health Canada and MDSAP inspections. Review and approve quality documentation, including SOPs, work instructions, and controlled records. Qualifications / Requirements: