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Regulatory Affairs Program Manager



Legal, Sales & Business Development, Operations
Remote · United States
Posted on Saturday, July 8, 2023

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 Regulatory Affairs Program Manager and member of the Merative Merge Healthcare Compliance Organization you will support the Quality Management System and provide regulatory support of development programs for new and existing products. As a key member of 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. In addition, and as appropriate, you will have the opportunity to contribute to and/or lead non-product development projects that seek to enhance overall operation of the regulatory or product engine functions, consistent with business needs.

Essential Job Duties:

  • 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, testing requirements, clarification and follow up of submissions under review
  • Participates or leads FDA, notified body, and other regulatory inspections
  • Provides business impact analysis of trends in international regulatory developments and proposes course of action to the company
  • Evaluates proposed products for regulatory compliance requirements internationally
  • Develops and implements global regulatory strategies for new and modified medical devices for intended markets as determined by the Product teams
  • Prepares and submits regulatory applications, as well as internal regulatory file documentation to achieve market clearances in US, Canada, EU and UK at a minimum
  • Acts as a core team member on product program teams, providing regulatory affairs feedback and guidance throughout the product development cycle
  • Reviews and signs-off on product/manufacturing changes for compliance with applicable regulations and guidances
  • 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; analyzes appropriate changes
  • Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures
  • Assists with activities related to the corrective and preventative action (CAPA) process
  • Builds quality into all aspects of their work by maintaining compliance to all quality requirements
  • Leads cross functional teams for assigned projects
  • Coaches, mentors and trains junior staff members

Required Professional and Technical Expertise:

  • Bachelor’s degree in a scientific or technical discipline required; advanced degree in Regulatory Affairs preferred.
  • Minimum of 5 years in the medical device industry in Regulatory Affairs
  • Proficient in preparing various types of regulatory submissions including 510(k), and EU Technical Files
  • Proficient in the preparation of Health Canada Medical Device Licenses
  • 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
  • Proficiency with Microsoft Word, Excel and PowerPoint
  • General understanding of product development process and design control
  • Excellent communication and interpersonal skills are essential
  • Effective research and analytical skills
  • Effective written and oral communication, technical writing and editing skill

Preferred Professional and Technical Expertise:

  • Extensive experience with the preparation of US FDA submissions
  • Specific experience with EU MDR submissions
  • Specific experience with software medical devices
  • Position is remote but physical office locations are in Hartland WI & Cambridge MA

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