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Merge by Merative · 2 weeks ago

Sr Manager, Regulatory Affairs

United States

Full-time

Remote

Senior Level, Lead/Staff

$145K/yr - $217K/yr

10+ years exp

Merative is dedicated to improving health outcomes through data, analytics, and software for the health industry. The Sr Manager, Regulatory Affairs will lead global regulatory strategy and compliance for Merge Healthcare’s medical imaging portfolio, ensuring adherence to regulations and fostering collaboration within a high-performing team.

Health CareMedical Device

Responsibilities

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

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

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

Lead and mentor a high-performing regulatory team, fostering collaboration and professional growth

Set clear performance goals, provide coaching, and recognize achievements

Qualification

Global medical device regulationsRegulatory submissionsLeadership experienceRegulatory Affairs CertificationSoftware as a Medical DeviceAnalytical skillsMicrosoft Office proficiencyInterpersonal skillsTechnical writing

Required

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, with demonstrated capability in leading high-performing teams, providing mentorship, and driving employee development and accountability

Experience interacting with global regulatory authorities, market authorizations, and regulatory inspections

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)

Experience with emerging regulatory trends, such as AI/ML and cybersecurity compliance preferred

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