Directly to Vice President Legal
Key Responsibilities and deliverables
- Develop regulatory strategy for complex projects.
- Develop and prepare submissions to regulatory agencies required to allow SOPHiA GENETICS products and services to be marketed in the America Region (FDA, Health Canada).
- Review and edit technical documents to be included in submissions and pull in subject matter experts as needed.
- Lead interactions with regulatory agencies and other external partners.
- Monitor regulatory agencies for changes in policies and procedures and implement changes as required to maintain registrations, maintain knowledge about applicable standards, directives and guidance’s necessary to facilitate notifications and submissions to regulatory agencies
- Implement and support regulatory compliance activities .
- Provide regulatory guidance and expertise, and train staff on regulatory procedures.
- Act as a liaison with other departments, e.g., Quality, R&D, IT, Legal
Knowledge, Skills and Experience Required
- Master degree in life sciences e.g. biology, pharmacy, biotechnology.
- Proven track record in Regulatory Affairs
- Fluency in spoken and written English, other languages an asset
- Knowledge, understanding and experience in life sciences, MedTech exposure a plus
- Knowledge of regulatory standards (FDA 21 CFR part 820, MDSAP) and regulatory agencies submissions
- 5 years of relevant experience
- Ability to leverage relationships across other departments and with prioritization.
- Excellent computer skills which includes working on electronic databases and good knowledge of MS office applications.
- Good knowledge and proven application of administration processes and systems.
- Results oriented, good attention to detail and problem-solving skills.
- Able to work independently as well as participating in a team of professionals
- Effective administration skills, good planning and organizing skills.
- Must use initiative, be proactive and have good follow-up skills.
Location : Boston
Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.