Sr Manager, Regulatory Affairs

Merative

13d•Hybrid

About The Position

Join a team dedicated to supporting the crucial mission of improving health outcomes. At Merative, you can apply your skills – and grow new ones – with colleagues who have deep expertise in health and technology. Merative provides data, analytics and software for the health industry. Our clients include providers, health plans, employers, life sciences companies and governments around the world. With industry-leading products and focused innovation, we help customers improve decision-making and performance so that together, we drive real progress in health. Learn more at merative.com Leads global regulatory strategy and compliance for Merge Healthcare’s medical imaging portfolio. This senior leadership role drives regulatory excellence across the product lifecycle, ensuring adherence to international regulations, standards, and guidelines. The Sr Manager, Regulatory Affairs provides strategic guidance, fosters cross-functional collaboration, and mentors a high-performing team to achieve business objectives and maintain regulatory compliance.

Requirements

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.
In-depth understanding of global medical device regulations, including: 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.
Specific experience with software medical devices (SaMD and SiMD).
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
Bachelor’s degree in a scientific or technical discipline required, or equivalent 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.

Nice To Haves

Experience with emerging regulatory trends, such as AI/ML and cybersecurity compliance preferred.
Professional medical device certification preferred, such as Regulatory Affairs Certification (RAC).

Responsibilities

Regulatory Strategy: Provide leadership and expert guidance on current, new, and emerging medical device regulations applicable to Merge Healthcare. Partner with cross-functional teams to develop and execute regulatory strategies to ensure compliance and enable market access.
Regulatory Submissions & Communication: Oversee registration, licensing, and certification of facilities and medical devices. Evaluate new products and modifications for regulatory impact to determine submission requirements. Review labeling and promotional materials for compliance with global regulations. Serve as primary liaison with regulatory authorities for submissions, adverse event reporting, recalls and compliance matters. Drive timely preparation and delivery of regulatory submissions and market authorizations.
Regulatory Compliance: Monitor regulatory changes and ensure timely implementation across processes and products. Investigate and resolve compliance issues, complaints, or inquiries from internal teams, customers, and regulatory authorities. Escalate any significant risks, issues, or concerns affecting Merge Healthcare’s products, services, or business operations to executive leadership. Drive continuous improvement of quality programs, processes, and systems to maintain compliance with applicable regulations and standards. Participate in internal audits, external audits, and inspections.
Leadership & Team Development: Lead and mentor a high-performing regulatory team, fostering collaboration and professional growth. Set clear performance goals, provide coaching, and recognize achievements.