Regulatory Affairs Manager (Consumer Medical Devices) - REMOTE POSITION

We are exclusively partnered with our successful CPG client to fill the role of Regulatory Affairs Manager (Consumer Medical Devices).

We are seeking a seasoned professional, a go-getter with great leadership qualities who makes things happen; someone with a very good understanding of U.S. FDA and also MDSAP. This is a regulatory role that requires someone who brings risk-based assessment skills.

This is a remote role with up to 15% travel max, perhaps 4x/year including annual meetings (U.S. and global), audits, and also professional development, training, and conferences. Position can be hybrid if you prefer to live/work near the office in Princeton, NJ.

This company owns well-known consumer goods brands and operates in a multi-site manufacturing plant environment, including for packaged regulated products. Awesome entrepreneurial culture at a company that genuinely cares about the people. This culture is low-ego, working collaboratively to make things happen. Very fast-paced and exciting organization, even relative to other CPG companies.

Nearly all of the company's medical devices are designed in the U.S., and you will be the primary point of contact for changes and product launches. You will provide the regulatory impact assessment and have impacts on the global business, where you will coordinate with regional needs.

Lots of opportunity to achieve breadth across the diversity of products in this role. You'll focus on medical devices, but there are cosmetics and other drugs that you can work on as you grow. This position will offer opportunities to grow in your strategic capabilities, rather than just managing tactical activities.

You will have two directs report on your team (one US focused and one focused on international team members throughout geographies), and colleagues to work with across all regulatory product categories. The company is doing a significant amount of remediation work to address MDRs and IDVRs in Europe; this role will be very involved in those projects.

The company is "building the plane while they're flying it" -- they're developing and updating SOPs, defining processes, determining workflows. We need someone who has the mindset of helping the team to build these processes, rather than someone who expects everything to already be in place.

KEY REQUIREMENTS

• Must have consumer medical device product experience.
• Experience authoring 510(k) / FDA submissions.
• Not risk averse. All OTC, consumer devices, risk is relatively low compared to other Class 2 medical devices.
• Represent the function on internal and external audits. Brings experience with FDA, MDSAP inspections, representing regulatory on these audits and inspections.
• Bachelor's degree or equivalent in a scientific discipline (Master's degree helpful).
• Minimum 4 years of regulatory experience, with at least 2 years' technical experience in obtaining regulatory clearance/approvals for medical devices in the U.S. and EU.
• Strong understanding of medical device quality system requirements (e.g., 21 CFR 820, ISO 13485, MDR/IVDR).

Excellent benefits. No visa sponsorship available for this position.

Please share your interest, and our managing partner Aaron Cleavinger will personally review your application. We can tell you all about the company and position on the first call.