Regulatory Affairs Specialist - Remote; Multiple Cities

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Posted 14 days ago United States Salary undisclosed
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Job Description

RQM+ is the largest medical device and diagnostics focused full-service regulatory and quality consulting firm in the world. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities.The Regulatory Affairs Specialist works with a team to develop and execute international strategies and submissions for regulatory approval of medical device products. The person in this role will work on a Regulatory team that covers one or several of these functions with our clients, depending on experience and growth opportunity. We are especially interested in candidates with EU MDR experience. RequirementsCoordinates, compiles and submits U.S, and/ or International regulatory submissions, including filing and/or creation of IDEs, Premarket Notifications, PMA Supplements, Change Notifications, Technical Documents, Technical Files, Design Dossiers, and other country-specific product registrations.Manages the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market productsFamiliarity with clinical evaluation reporting (CERs), clinical data, and post-market data collection and summarization. Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.Represents department on cross-functional product development and manufacturing support teams. Guide teams to provide content for US and/or International submissions, participates in design reviews as needed.Communicates with and maintains productive, constructive relationships with external customers as required - US FDA, Health Canada, in-country regulatory representatives, and notified-bodies.Participates in project development teams and reviews plans, reports, risk management and design reviews associated with product and process projects intended for inclusion in regulatory submissions.Assist in regulatory due diligence for potential and new acquisitions Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teamsEducation and Work ExperienceBachelor level degree required preferably in engineering, chemistry, physics, biology or related life science2-15 years related work experienceMinimum of 1 year of experience in the medical device industry requiredConsulting experience preferredWorking knowledge of FDA Regulatory RegulationsEU MDR a plusBeing an industry leader in regulatory and quality consulting is just the beginning for RQM+. We consider our Associates our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.