Sr Manager, Regulatory Affairs

2 weeks ago

Mississauga, Canada Merative Full time

Evaluate new products and modifications for regulatory impact to determine submission requirements.**Core Competencies -** Ability to work independently with minimal supervision in a team setting to meet defined objectives.Ability to influence change and champion initiatives to drive change in the organization.Excellent interpersonal, communication, and collaboration skills.Proficiency with Microsoft Word, Excel and PowerPoint required.Effective research and analytical skills.Effective written and oral communication, technical writing and editing skills.**Technical Skills:** * 21 CFR Part 820 US Quality Management System Regulation* SOR/98-282 Canada Medical Device Regulation* 2017/745 EU Medical Device Regulation* Proficient in the preparation of medical device regulatory submissions to global regulatory authorities, e.g. US FDA, Canada, EU, Australia, UK, and Brazil.**Supervisory Skills:*** At least 10 years’ technical leadership or management experience in a medium-to-large sized regulated medical device organization* Track record of building and leading high-performance teams**Qualifications Required** -**Education Requirements:*** Bachelor’s degree in a scientific or technical discipline required, or equivalent experience.* Professional medical device certification preferred, such as Regulatory Affairs Certification (RAC).**Experience:*** Proven experience (10+ years) in healthcare technology, life sciences, or similar regulated industries, preferably with a focus on Software as a Medical Device (SaMD).* At least 5 years’ leadership or management experience in a medium to large-sized organization.* Experience interacting with global regulatory authorities, market authorizations, and regulatory inspections.Specific experience with software medical devices (SaMD and SiMD).Experience with emerging regulatory trends, such as AI/ML and cybersecurity compliance preferred.* Remote first / work from home culture* Flexible vacation to help you rest, recharge, and connect with loved ones* Paid leave benefits* Health, dental, and vision insurance* 401k retirement savings plan* Infertility benefits* Tuition reimbursement, life insurance, EAP – and moreMerative is a place to grow. We offer opportunities to apply your skills — and develop new ones — with colleagues who have deep expertise in health and technology. At Merative we’re driven and professional, but treat each other with compassion and respect. Roles at Merative include product design and development, technology innovation, product and account management, sales and consulting, communications and marketing, management, operations and more.### Introduce Yourself
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