Program Manager, Regulatory Affairs

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

As Program Manager, Regulatory Affairs – Post Market and member of the Merge Regulatory Affairs organization you will support the Quality Management System and provide regulatory support of development programs for new and existing products, with focus on post-market aspects, including Regulatory Reporting. As a key contributor to the cross-functional product development teams that you support, you will actively collaborate to enable efficient and compliant, full life cycle product management to satisfy business, market, and regulatory requirements.

This role can be remote based in either the United States or Canada.

Responsibilities:

• Under minimal supervision, acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, post-market submissions, testing requirements, clinical study requirements, or clarification and follow up of submissions under review.

• Participates in FDA, notified body, and other regulatory inspections.

• Evaluates proposed products for regulatory compliance requirements.

• Under supervision, assists with regulatory applications, as well as internal regulatory file documentation to achieve market clearances in US, Canada, EU, UK, Australia, Japan and Brazil as applicable.

• Initiates product holds, as needed, where market authorizations have not been achieved.

• Acts as a core team member on development teams, providing regulatory affairs feedback and guidance throughout the product development cycle.

• Reviews and signs-off on product changes including manufacturing changes for compliance with applicable regulations and guidances in US, Canada, EU, Brazil, Japan and Australia.

• Collaborates with regional business partners to support international product registrations.

• Assists with the development of regulatory department policy and procedure implementation.

• Reviews device labeling and promotional materials for compliance with global submissions and applicable regulations.

• Stays current on new regulations through regulatory intelligence monitoring.

• Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures

• Builds quality into all aspects of their work by maintaining compliance to all quality requirements.

• Leads cross functional teams for assigned projects

Core Competencies:

• Must be well versed in the medical device quality system regulations and international regulatory requirements for medical devices

• Proficient knowledge of global regulatory submission requirements for medical devices

• Proficient in the preparation of medical device regulatory submissions to global regulatory authorities, e.g. US FDA, Canada, EU, Australia, UK, etc.

• Excellent interpersonal, communication, and collaboration skills

• General understanding of product development process and design control

• Proficiency with Microsoft Word, Excel and PowerPoint required

• Effective research and analytical skills

• ·Effective written and oral communication, technical writing and editing skills

• Ability to work independently with minimal supervision

• Additional Preferred Competencies:

• Extensive experience with the preparation of US FDA and EU MDR submissions

• Specific experience with software medical devices (SaMD and SiMD)

• Specific experience with medical device post-market surveillance and vigilance reporting

Education Requirements:

• Bachelor’s degree in a scientific or technical discipline required; advanced degree in Regulatory Affairs preferred

• Professional medical device Regulatory or Quality certifications preferred

Experience

• Minimum of 5 years healthcare medical device or life sciences industry, or 3 years’ experience with job title/experience related to Quality Engineer, Quality Systems or Regulatory Affairs

Required Training:
 

• Merative Employee Code of Conduct

• Merative Corporate IT Security Policy

• HIPAA Overview: Health Insurance Portability and Accountability Act

• Cybersecurity Awareness

• Merative ITS-POL-001 Corporate Security Policy

• Merative ITS-POL-002 End User Acceptable Use Policy

• Merative PRI-POL-001 Privacy by Design

• WHPS 110 Privacy and Security Supplemental Training

• Bystander Training

• Anti-Bullying Training HR-POL-002 Prohibiting Harassment, Bullying and Other Inappropriate Content

• HR-POL-007 Equal Employment Opportunity and Anti-Discrimination Policy

• Merge Healthcare Quality Management System as required by QS-2036 Training Matrix

Work Environment

The work environment characteristics here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Office environment: Hybrid (Mississauga, ON Canada or Hartland, WI USA) or Remote

· Travel: Minimal

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.