Regulatory Affairs Specialist (Remote-Us) Jobs

Merative

Job Brief

We have a vacancy of Regulatory Affairs Specialist (Remote-Us) in our company, Merative. This vacancy is based in Ann Arbor MI. Please go through the job detail mentioned below.

Position Title: Regulatory Affairs Specialist (Remote-Us)
Company: Merative
Work Type: Full Time
City of work: Ann Arbor MI
Salary: Full-time
URL Expiry: 2022-12-27
Posted on: us.jobsoffices.com

Job Detail

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 Specialist and member of Merative 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.

Essential Job Duties: ·
  • Under moderate 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, prepares and submits regulatory applications, as well as internal regulatory file documentation to achieve market clearances in US, Canada, EU, 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
  • Build quality into all aspects of their work by maintaining compliance to all quality requirements.
Basic Qualifications (minimum requirements needed to perform this job)
  • BA/BS in a scientific discipline
  • Minimum of 5 years healthcare medical device or life sciences pharmaceutical experience, or 2 years’ experience with job title/experience related to Quality Engineer, Quality Systems or Regulatory Affairs
  • Knowledge of global regulatory submission requirements for medical devices · 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
Preferred Skills
  • Understands medical device regulations in accordance with USA, Canada, Brazil, Japan, EU, UK, Australia and Singapore requirements
  • Experience with diagnostic imaging and/or digital healthcare device
  • Experience with software medical devices
Professional certifications Education and Certification Requirements -Bachelor’s degree in a scientific or technical discipline required; advanced degree preferred
  • Professional certifications preferred: RAPS, RAC
Work Environment · Cambridge MA, Hartland WI or Remote location
Minimal travel
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

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