Stryker

Regulatory Affairs Analyst (Hybrid)

São Paulo, State of São Paulo, Brazil

$60,000 – $90,000Compensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Regulatory AffairsIndustries

Requirements

Candidates should possess a Bachelor’s degree in a healthcare-related field and previous experience in the medical devices industry is required. Intermediate to advanced English proficiency is necessary, and knowledge of Ordinance 384/2020, RDC 751/2022, and Quality Standard 665/2022 is preferred.

Responsibilities

The Regulatory Affairs Analyst will be responsible for product registrations, item maintenance, certifications, and supporting import clearance processes, prioritizing and managing regulatory submissions for changes and renewals across all risk classes. They will also interact with Health Authorities by preparing and submitting dossiers, responding to inquiries, and monitoring approval status, while providing cross-functional communication and supporting audits and tender processes. Furthermore, the role involves delivering accurate data for monthly KPIs and management reports, maintaining organized RA intelligence files, and identifying opportunities for continuous improvement.

Skills

Regulatory Submissions
Dossier Preparation
Health Authorities
Import Clearance
Ordinance 384/2020
RDC 751/2022
Quality Standard 665/2022
Data Analysis
KPI Reporting
Audit Support
Tender Processes

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Key Metrics

Kalamazoo, MichiganHeadquarters
1941Year Founded
$423.3MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Benefits

Medical & prescription plans
Supplemental health benefits
Flexible Spending accounts
Employee Assistance Program
Short-term & long-term disability
Tuition reimbursement
401(k) plan
Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.
Rapid tech advancements risk obsolescence of Stryker's current products.
Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.
Entry into the peripheral vascular segment diversifies Stryker's market presence.
Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.
The orthopedic implants market growth benefits Stryker's expanding product line.
Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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