FDA Digital Health/Medical Device Attorney

Min 4 yrs required

Full-time

No

seeks a talented and experienced FDA regulatory attorney to join our team! Our attorneys serve leading-edge Digital Health, and Medical Device companies who share our passion for helping people live longer and healthier lives. We are hiring a stellar candidate with at least four years of FDA medical device experience for a work-anywhere position (PST --> EST).

What it’s like to work here

Everyone on our team is aligned with our core values. We are self-motivated, collaborative, take a creative approach to problem-solving, and are comfortable with technology and working in a fully remote/virtual environment.

We are always growing, learning, and adapting, in and out of the office. Our teams are crazy smart and direct and we ask hard questions and challenge each other to constantly improve our work. We are driven but team oriented. We love to explore, challenge and have a lot of fun along the way.
At Nixon Gwilt Law, you will find:

A healthy, diverse, and supportive working environment

Reasonable minimum billable requirement (25 hours/week), allowing you to balance life and work

Flexibility to self-determine total compensation

Lots of opportunities to connect with the team through regular virtual and in-person (when it is safe!) events

A culture of continuous learning and mentorship

Kind, brilliant, and collaborative colleagues

Marketing resources and support so you can develop your personal brand and grow your practice

Compensation and Benefits

We offer full-time employment with benefits, including platinum-level health insurance and HSA, FSA, dependent care, dental and vision insurance, short-term disability insurance, 401(k) with match (after the first year), a home office allowance, and a PTO policy which includes paid holidays, vacation time, and parental leave. Total compensation includes base salary (based on experience) for a minimum of 25 hours billable per 40-hour work week, quarterly compensation based on project management, annual performance bonus, and origination credit.

Qualification and Experience On Day One, a successful candidate will have: Expertise in advising clients on market authorization strategies for medical devices and mobile/digital health technologies, (including Software as a Medical Device) An understanding and ability to support clients in the development of quality management systems and pre-clinical/clinical study designs Experience interfacing with the FDA through the device regulatory pre-submission and submission processes Experience in navigating the ever-changing healthcare regulatory landscape The ability to identify and evaluate legal and business risks and opportunities for healthcare companies A keen interest in and curiosity about healthcare innovation Enjoyment of sharing knowledge with teammates, and working collaboratively when you need help It's a bonus, but not required, if you have significant experience in one or more of these areas: Digital health and telemedicine Post-market surveillance Regulatory investigations Supplier evaluation Import/export activities Software Development Healthcare reimbursement

Legal