Regulatory Affairs Specialist (MedTech) – Johnson & Johnson Canada

Description

The Johnson & Johnson Medical Device company is recruiting for a Regulatory Affairs Specialist, located in Markham Ontario, Canada.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

Directive:

Reporting to the Director of Regulatory Affairs, the successful candidate will handle medical device submissions and manage the products through its product lifecycle. The Regulatory Specialist will work collaboratively with the local and global business partners to provide regulatory strategies and solutions to address business needs. This role will work on-site in our Markham, ON office 3 days per week and will have the option to work from home the other 2 days.

Specific accountabilities include the following:

• Provide regulatory expertise to business partners and mentor Regulatory Associates with less experience.
• Develop and implement regulatory strategies for medical devices to meet and exceed business objectives.
• Conduct peer review of regulatory submissions and provide constructive feedback to Regulatory Specialists and Associates
• Handle all regulatory aspects of the product lifecycle from pre-market to post-marketing phase including reviewing and approving promotional material in compliance with corporate and government requirements.
• Develop and maintain collaborative relationship with Health Canada and business partners regarding submission strategy, regulatory pathway development, submissions status, and special access processes.
• Participate and support Health Canada audits and facilitate source company audits.
• Build and maintain relationships with internal and external stakeholders.
• Understanding of Johnson & Johnson business requirements and processes
• Maintain awareness of new industry issues, trends and changes in regulation and policy. Coordinate comments on proposed regulations and policies.
• Other regulatory duties, as the need arises.

Qualifications Candidate Criteria:

• Bachelor’s level degree required ; technical subject area strongly desired.
• Minimum 3-8 years of experience in Regulatory Affairs in Medical Device or Pharma required .
• Completion of Post Graduate training in Quality and/or Regulatory; RAC (Regulatory Affairs Certification) preferred.
• Sound knowledge of Canada’s Food and Drugs Act and Regulations, Medical Device Regulations and relevant policies and guidelines
• Excellent verbal and written communication skills
• Ability to develop and maintain strong working relationships with collaborators.
• Demonstrated leadership skills
• Demonstrated ability to lead regulatory submission activities
• Project management and time management, organizational and multi-tasking skills
• Detail oriented and ability to align with business objectives
• Excellent analytical problem-solving skills
• Excellent skills with Microsoft Word and Excel (V Lookups & Pivot Tables)

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential.