Sr Manager, Regulatory Affairs

Merative • Full-time • Remote – United States, United States of America • 16h ago

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.

Responsibilities -

Regulatory Strategy:

Provideleadershipand expertguidanceoncurrent,new,and emergingmedical deviceregulationsapplicable to Merge Healthcare.

Partner withcross-functionalteams todevelop and executeregulatory strategiesto ensure compliance and enable market access.

Regulatory Submissions & Communication:

Overseeregistration, licensing,and certification of facilities and medical devices.

Evaluatenew products and modifications for regulatory impacttodeterminesubmission requirements.

Review labeling and promotional materials for compliance with global regulations.

Serve asprimaryliaison with regulatory authorities for submissions,adverse event reporting,recallsand compliance matters.

Drivetimelypreparation anddeliveryofregulatory submissions andmarket authorizations.

RegulatoryCompliance:

Monitor regulatory changes and ensuretimelyimplementation across processes and products.

Investigate and resolve compliance issues, complaints, or inquiries from internal teams, customers, andregulatory 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 tomaintaincompliancewith applicable regulations and standards.

Participate in internalaudits, 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.

Core Competencies -

Ability to work independently with minimal supervision in a team settingto meet definedobjectives.

Ability to influence change and champion initiativestodrive change in the organization.

Excellent interpersonal, communication, and collaboration skills.

Proficiencywith Microsoft Word,Exceland PowerPointrequired.

Effective research and analytical skills.

Effective written and oral communication, technicalwritingand editing skills.

Technical Skills:

In-depthunderstanding 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 andSiMD).

Experience with emergingregulatory trends, such as AI/ML and cybersecurity compliancepreferred.

Supervisory Skills:

At least10years’ technical leadership or management experience in amedium-to-largesizedregulatedmedical deviceorganization

Track recordof building and leading high-performance teams

Qualifications Required -

Education Requirements:

Bachelor’s degree in a scientific or technical disciplinerequired, or equivalent experience.

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

Experience interacting with globalregulatoryauthorities, market authorizations,and regulatory inspections.

Work Environment:

The workenvironmentcharacteristics here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonableaccommodationsmay be made to enable individuals with disabilities to perform the essential functions.

Office environment,hybridor remote work from home

Travel:~10%

Compensation

The salary range provided in this job posting is intended to reflect the general market value for the position. The actual salary offered may vary based on factors such as the candidate’s experience, qualifications, skills, and the specific requirements of the role. This range may also be subject to change as market conditions evolve. We encourage open communication throughout the interview process to discuss compensation expectations. For base-salary + commission sales roles, the range represents On-Target Earnings.

Min – Max :

$144,632.60 - $216,948.90 (USD)

Benefits

The benefits described represent the current offerings at our organization, however, benefits are subject to change and may vary by location and employment status. We strive to provide a comprehensive benefits package that supports our employees’ health, wellness, and financial goals. Please note that benefits may be discussed in more detail during the hiring process.

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 more!

It is the policy of Merative to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Merative will provide reasonable accommodations for qualified individuals with disabilities.

Merative participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees