Summary

Posted: Mar 16, 2021

Weekly Hours: 40

Role Number:200230389

The Health group is looking for an International Regulatory and Quality Affairs Specialist to help support dili...Summary

Summary

Posted: Mar 16, 2021

Weekly Hours: 40

Role Number:200230389

The Health group is looking for an International Regulatory and Quality Affairs Specialist to help support diligence and execution of international expansion for Apple's Health features. 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 organization who works closely together to form relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.

Key Qualifications

• 5+ years of medical device experience in a regulatory and/ or quality role, with at least 3+ years focused in international programs
• Significant experience in leading interactions with regulatory health authorities in the US and abroad
• Preparing global product submissions required including STED, CDST and other global templates
• Solid understanding of US, EU, APAC, LATAM, ASEAN and other global regulations that affect Class I, II and III devices
• Proven knowledge of clinical investigations, validations and GCP requirements in the US and abroad
• Specialist in technical writing, including distilling complex information into geo-specific filings, submissions, slides and other communication formats
• Significant expertise in global quality standards, including ISO 13485, ISO 14155, and related technical product-specific standards
• Track record of executing complex gap analyses for products/ programs against global regulations, standards and guidance in order to drive RA/QA strategy for international expansion programs

You will be the primary lead representing the Regulatory/Quality team on a diverse array of initiatives and new product development programs, with the goal of marketing new technologies in select geographies. You will develop a variety of solutions to regulatory challenges and will exercise independent judgment in settling and communicating appropriate regulatory/quality actions 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. You'll also be responsible for identifying impacts of international regulations, standards and guidance to our Quality Management System and perform routine monitoring for changes abroad that may impact the team.

Education & Experience

B.S. degree or equivalent in a life science, legal or business field
M.S/ PhD/ post-secondary education preferred

Additional Requirements

• - Shown competence in determination of appropriate global regulatory requirements for new products or product changes.
• - Partnering with and across a broad swath of other Apple teams to set regulatory / quality strategy and "look around corners" to anticipate business impact
• - Strong organizational and management skills
• - Excellent communication skills, both verbal and written
• - Comfortable with presenting assessments and information to broad, multi-disciplinary teams
• Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants.