Regulatory Affairs Associate (Principal) Medical Devices

Imagine what you could do here. At Apple excellent ideas have a way of becoming great products services and customer experiences. Bring passion and dedication to your job and theres no telling what you could accomplish. The people at Apple dont just build products we craft the kind of wonder thats revolutionized entire Health group is looking for a Principal Regulatory Affairs Associate to help drive strategy and submissions for health products. If you are passionate about the health space and want to have an incredible impact here at Apple this could be the role for you. We are an efficient team who works closely together to build relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands. We come to Apple to think creatively about how to launch products within a rigorous regulatory structure for medical

You will represent the RA/QA team on a diverse array of regulatory initiative teams and new product development with the goal of obtaining approvals for new technologies. You will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in settling and communicating appropriate regulatory action and requirements. This role will involve assessment of regulatory impact for new and modified Class I II and III products including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in the US and globally.

B.S. ME/EE/BME/CS degree or equivalent in any engineering disciplinen10 years of medical device experience in a regulatory role with at least 5 years as a principal manager or experience in leading interactions with the US Food u0026 Drug experience preparing regulatory filings including pre-submissions 510(k)s De Novos and working knowledge of US regulations that affect Class I II and III with Software as a Medical Device (SaMD) and algorithm- or sensor-based products including how regulatory strategy interacts with clinical study design and algorithm to be onsite; this role is a hybrid in-person position.

Global regulatory strategy experience (e.g. EU MDR) is a strong background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal as part of a focused project competence in determination of appropriate global regulatory requirements for new products or product changes. nPartnering with and across engineering teams to set regulatory strategy. nStrong organizational and management skills. nExcellent communication skills both verbal and written.