Regulatory Affairs Specialist - Remote; Multiple Cities

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.

Requirements

• Coordinates, 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 products
• Familiarity 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 teams

Education and Work Experience

• Bachelor level degree required preferably in engineering, chemistry, physics, biology or related life science
• 2-15 years related work experience
• Minimum of 1 year of experience in the medical device industry required
• Consulting experience preferred
• Working knowledge of FDA Regulatory Regulations
• EU MDR a plus

Being 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!