The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. They must enjoy problem solving and possess practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for medical products.
Key job responsibilities
• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
• Develops global regulatory strategies for new and modified products.
• Prepares and submits regulatory submissions to health agencies.
• Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
• Provides regulatory assessment for manufacturing, design changes and product risk assessment.
• Reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations.
• Plans, schedules, and arranges all activities to support regulatory timelines.
• Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during regulatory audits.
• Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
• Supports the product release process.
• Acts as an SME for internal and external audits and inspections by internal teams or external regulatory authorities.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, and governing procedures and processes.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Reviews protocols and reports to support regulatory submissions.
• Creates, reviews and approves engineering change requests.
• Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
• Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
• Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams
About the team
The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe, effective and high-quality medical products for at home, mobile health and wellness customers.
BASIC QUALIFICATIONS
- 5+ years of working directly with engineering teams experience
- 5+ years of technical product or program management experience
- Experience managing programs across cross functional teams, building processes and coordinating release schedules
- · Bachelor’s Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)
- · 5-7 years of experience in regulatory submissions for In Vitro Diagnostic Devices, Pharmaceutical and/or Biologics (small molecules & biologics)
- · 5-7 years of experience working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
- · 5-7 years of experience in a regulated industry with experience working with biologics and/or Class II and/or Class III devices.
- · Prior experience with phase 1, 2 and 3 design including end of phase health authority interactions
- · Knowledge and understanding of guiding principles in device and drug development such as benefit/risk profile, statistical design or drug dose selection
- · Ability to work effectively on project teams.
- · Has a strong attention-to-detail
- · Strong written, verbal, presentation, and organizational skills.
- · Experience with medical device software requirements.
- · Ability to identify risk areas and escalate issues as appropriate
PREFERRED QUALIFICATIONS
- Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership
- · Regulatory Affairs Certification (RAPS)
- · Drug and Biologics regulatory filing experience
Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.
Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company’s reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $133,900/year in our lowest geographic market up to $231,400/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit https://www.aboutamazon.com/workplace/employee-benefits. This position will remain posted until filled. Applicants should apply via our internal or external career site.