What are the responsibilities and job description for the Post Market Specialist - Health position at Apple?
Summary
Posted:
Weekly Hours: 40
Role Number:200510291
Our ever-evolving suite of fitness and Health features in iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices - strengthening our commitment to leave the world better than we found it. If you care deeply about impacting user health in meaningful ways, we'd love to talk with you. Apple Health is looking for a Post Market Surveillance Specialist to support complaint handling and related post market activities. The Post Market team is responsible for performing the domestic and international product surveillance activities.
Key Qualifications
- 3 years of direct work experience in medical device quality functions, CAPA, complaint handling, or field action is preferred.
- Detailed knowledge of FDA's 21 CFR 820, 21 CFR 803, ISO 13485:2016, ISO 14971, MDD, EU MDR, MDSAP
- Proven understanding of receiving, evaluating, and investigating complaints.
- Direct experience with submitting Adverse Event Reports to the US FDA
- Ability to develop and implement post market processes for new product development activities
Description
This role is part of the Post Market Surveillance (PMS) team supporting Apple's medical products. In this key role, responsibilities will include: - All administrative activities associated with the complaint handling process including, but not limited to, reviewing, managing and closing complaints records in the system. - Partner with cross-functional teams such as clinical, engineering and customer service groups to ensure product investigations are completed, as well as maintain ongoing tracking and trending of complaints. - Assess post market data and update risk management documentation . - Evaluate complaint documentation for completeness and consistency, and complete additional actions as vital to close the complaint file. - Submit timely Adverse Event Reports to the US FDA, when appropriate. - Conduct post market surveillance activities to analyze post-market quality issues and trends. - Identify potential issues to continuously improve product safety. - Serve as the subject matter authority to the Company for Complaints and Post Market Surveillance. - Assist in the preparation and sending of post-market reports and submissions. - Support different project work and process improvements, as needed.
Education & Experience
BS/MS degree in Engineering, Math, Statistics, science-related field, or equivalent technical experience
Additional Requirements
- - Ability to take initiative in an ambiguous and fast-paced environment
- - Excellent verbal and written communication skills with ability to lead meetings
- - Strong organizational, time management, and influence skills
- - Experience with risk management is highly preferred
- - Experience with high volume complaints environment
- - Experience in working on software products within a quality or regulatory system
Pay & Benefits
- At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $102,000 and $170,100, and your base pay will depend on your skills, qualifications, experience, and location.
Apple employees also have the opportunity to become an Apple shareholder through participation in Apple's discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple's Employee Stock Purchase Plan. You'll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses - including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. about Apple Benefits.
Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.
Salary : $102,000 - $170,100
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