The Qfix Regulatory Affairs Manager works with a high level of autonomy to bring medical devices to market and ensure ongoing compliance. They are responsible for providing key functional teams with ongoing developmental opportunities. The RA Manager interprets regulatory requirements and recommends to senior management specific activities and resources required to support this strategy. They participate on cross-functional teams, develop global regulatory strategies, author / review / approve regulatory submissions.Essential Duties and Responsibilities:Represent the company in interactions with external organizations including the FDA, sponsors, and other organizations; serve as a primary contact during all premarket activities and approve all responses to FDA reviewer questions.Develop/approve and implement regulatory strategies including global strategies that ensure procedures and policies meet applicable regulations.Plan and manage key projects to ensure resources and support are provided as needed and report metrics to upper management.Provide expert review of FDA submissions, design dossiers, technical files, post-market submissions, and other regulatory documentsMinimum Qualifications:Bachelor's degree in a scientific discipline. 5 to 10 years of experience in regulatory affairs in the medical device, biotechnology or contract research industry.Regulatory experience in medical devices with Class I, II. Extensive knowledge of medical device regulations with an emphasis on US and EU regulations. Experience with additional international regulations preferred.Ability to understand, interpret, and explain complex development details and regulations to non-experts.Expertise with 510(K) submissions Thorough knowledge of FDA, QSR, GMP and ISO standards.Preferred Qualifications:Previous supervision and eperience within Radiology/Radiotherapy industry is a plus. RAC certified
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.