Senior International Quality and Regulatory Compliance Associate
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Description
The Health group is looking for an International Quality and Regulatory Compliance Associate to support regulated medical device software compliance. 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 establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.
The International Quality and Regulatory Compliance Associate is part of the quality team supporting Apple's medical products. The team is responsible for working closely with cross functional teams to ensure product conforms to specified requirements globally. The International Quality and Regulatory Compliance Associate drive the execution and implementation of OUS requirements.
This is a site-based role. ","responsibilities":"Ensures alignment of interpretation / implementation of regulatory requirements for site quality management systems (e.g China)
SME on new or revised regulatory compliance standards globally; DRI on the regulatory intelligence team on the implementation of OUS regulatory standards
Responsible for determination and implementation of region specific regulatory compliance requirements related to areas such as adverse event reporting / vigilance / corrections & removals, labeling, importation / distribution, QMS requirements and change notification
Create and maintain country requirement matrices
Evaluate agreements for in country authorized representative and ensure ongoing fulfillment of responsibilities
Ability to prepare and present complex material in an easy-to-understand manner to both internal and external stakeholders
Proven competence in determination of appropriate global regulatory requirements for new products or product changes.
Strong project management skills with the ability to work under strict timelines and successfully meet deadlines and expectations
Partnering with and across engineering, marketing, post market and other corporate teams to execute quality compliance needs
Preferred Qualifications
Experience working on software medical device products within a quality or regulatory system.
Experience identifying the need for Quality Improvement projects and implementing recommended enhancements to the QMS
Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.
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Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.
Strong organizational and leadership skills.
Excellent communication skills, both verbal and written. Ability to take initiative in an ambiguous and fast fast paced environment
Strong organizational, time management, and influence skills
Minimum Qualifications
B.S. ME/EE/BME/CS degree or equivalent in any engineering discipline
5+ years of experience on international/OUS/ROW medical device projects in either a quality or regulatory role
Strong understanding of Quality Management Systems (QMS), ISO 13485, and international quality requirements
Strong working knowledge of US, EU, APAC, LATAM, ASEAN and other global regulations that affect Class I, II and III devices
Strong knowledge of and experience working with and implementing global regulations
Strong analytical skills and the ability to conduct and document gap analyses
Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant .
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 $146,300 and $244,100, 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. Learn more 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.
Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion
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