Regulatory Affairs -Remote Based Position
About the job
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.
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!
Regulatory Affairs Specialist
All positions are full-time and remote based. Direct hire & contract positions are available.
*Candidates must have 2-10 years of RA experience with medical devices and/or diagnostics to be considered.
The Regulatory Affairs Specialist works with a team to develop and execute international strategies 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.
• Coordinates, compiles and submits U.S, and/ or International regulatory submissions, including filing and/or creation of PMAs, IDEs, Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations.
• Develop IDE/ 510K/ PMA (US) and Technical Files/ Design Dossiers (EU) submissions for class II and III medical devices.
• Manages the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products
•Carries out Post Market Surveillance activities such as CAPA support, post market risk management, recalls, and complaint handling.
• Handling submissions (PMA, 510ks, de novo, IDE, HDE, combination products)
Supporting basic and advanced market entrance, providing acquisition due diligence, UDIs, and clinical evaluation reporting (CERs).
• 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 maintain productive, constructive relationships with external customers as required – US FDA, Health Canada, in-country regulatory representatives, and notified-bodies.
• Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
• 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
- 2-10 years of experience in Regulatory Affairs
- Bachelors degree
- Must be U.S. Citizen or have a Greencard.
We are interested in every qualified candidate who is eligible to work in the United States as a permanent resident. However, we are not able to sponsor visas.
Learn more here
Job posted: 2021-02-03