Director Of Regulatory Affairs - Medical Device/Pharma

Full time

This is on site, 5 days a week role – for Canada, Scarborough location.

As the Regulatory Director for a medical device company, your role would involve leading the regulatory process for global regulatory bodies such as the FDA (United States), Health Canada (Canada), ANVISA (Brazil), and regulatory bodies in Europe. You would be responsible for ensuring compliance with the product registration requirements for medical device advanced and traditional wound care dressings.

Qualifications

· University Degree

· 10 to 12 years working experience

· Experience in Regulatory Affairs

· Experience working directly with the FDA on regulatory filings/strategy is required. Similar experience with Health Canada is an asset.

· Experience with electronic submissions/the electronic submission process

· Knowledge of how regulatory agencies operate, structure and process

Responsibilities

· Regulatory Strategy: Developing and implementing regulatory strategies for the approval and commercialization of wound care and advanced wound care products. This includes staying updated with relevant regulations and guidelines.

· Interfacing with regulatory agencies: As the Regulatory Director, you would serve as the primary point of contact for regulatory agencies in the various regions. You would engage in communications with these agencies, respond to their inquiries, provide requested information, and address any concerns or issues that may arise during the regulatory review process.

· Staying updated on regulatory requirements: It would be crucial for you to stay informed about the evolving regulatory landscape in the medical device industry, particularly in the areas of wound care dressings. This would involve monitoring changes in regulations, guidelines, and standards, and ensuring that products remain compliant with the latest requirements.

· Product Registration: Managing the preparation and submission of regulatory applications for product registrations or clearances. This includes compiling relevant data and documentation, such as technical files, clinical data, and labeling information.

· Collaborating with cross-functional teams: You would work closely with cross-functional teams including R&D, quality assurance, clinical affairs, and marketing, to ensure regulatory compliance throughout the product development lifecycle. This collaboration would involve providing regulatory guidance, participating in product design and development discussions, and ensuring that regulatory considerations are integrated into the overall business strategy.

· Communication with Regulatory Authorities: Interacting and communicating with regulatory authorities, such as the FDA, Notified Bodies, or other regulatory agencies. This includes responding to inquiries, addressing regulatory concerns, and participating in meetings or audits.

· Preparing and submitting regulatory submissions: You would be responsible for preparing and submitting regulatory filings, such as 510(k) submissions for the FDA, medical device license applications for Health Canada, and similar submissions for other countries. This would involve compiling the necessary documentation, ensuring accuracy and completeness, and following the specific regulatory guidelines for each region.

· Risk Management: Overseeing the implementation of risk management processes, including risk assessments and the development of risk management plans. This involves identifying and mitigating potential risks associated with the use of wound care products.

· Labeling and Advertising Compliance: Ensuring that product labeling, promotional materials, and advertising campaigns comply with regulatory requirements and guidelines. This includes reviewing and approving labeling content and advertising materials.

· Post-Market Surveillance: Monitoring and evaluating post-market data, including adverse event reports and product complaints. This involves assessing the need for corrective and preventive actions and reporting incidents to regulatory authorities when required.

· Training and Education: Providing guidance and training to internal teams, such as R&D, marketing, and sales, on regulatory requirements and processes related to wound care products.

· Regulatory Intelligence: Keeping abreast of new or changing regulations, guidelines, and industry trends in the wound care and advanced wound care sectors. This includes monitoring regulatory developments and assessing their impact on product strategies and compliance.

Specific responsibilities may vary depending on the company, product portfolio, and geographical regions in which you operate. It's essential to maintain a comprehensive understanding of applicable regulations and actively collaborate with internal and external stakeholders to ensure compliance and successful market access for your medical device wound care and advanced wound care products.