Key Responsibilities:

Develop and maintain a deep understanding of all applicable regulations and guidelines for our products and markets.
Collaborate with cross-functional teams to ensure all product development processes are in compliance with regulatory requirements.
Prepare and submit all necessary documentation to regulatory agencies for product approvals, including but not limited to, pre-market notifications, 510(k) submissions, and pre-market approval applications.
Assist in the development and maintenance of regulatory strategies for new and existing products.
Review and approve labeling, promotional materials, and product changes to ensure compliance with regulations.
Monitor changes in regulations and communicate any potential impact to the business.
Maintain accurate and up-to-date regulatory documentation and submission records.
Participate in regulatory agency inspections and audits.
Provide support for post-market surveillance activities, including adverse event reporting.
Collaborate with international regulatory teams to ensure compliance with global regulations.

Qualifications:

Bachelor's degree in a scientific or technical discipline.
Minimum of 3 years of experience in regulatory affairs within the medical device or pharmaceutical industry.
Strong knowledge of FDA regulations, guidelines, and submissions processes.
Experience with international regulations, including CE Marking and Health Canada submissions, is preferred.
Excellent written and verbal communication skills.
Strong attention to detail and ability to manage multiple projects simultaneously.
Ability to work independently and in a team environment.
Proficient in Microsoft Office and regulatory submission software.
Regulatory Affairs Certification (RAC) is a plus.

If you are a self-starter with a passion for regulatory affairs and a desire to make a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.

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