Regulatory Reporting Specialist (Hybrid) at Stryker

Fort Lauderdale, Florida, United States

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree (B.S. or B.A.), preferably in Science, Engineering or related field
0–2 years of experience as a regulatory or quality professional in a regulated manufacturing environment
Ability to manage multiple tasks and meet deadlines
Preferred
Experience with post-market MDR/MIR reporting
Applied knowledge of US and International Medical Device Regulations and Standards including but not limited to: FDA: CFR 21 Part 803 (MDR), and CFR 21 Part 820 (QSR), MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System), ISO 13485
Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development and Marketing and Quality
Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality

Responsibilities

Review reports of customer complaints and assess them for MDR / MIR reportability to FDA / Competent Authorities
Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines
Partner with Quality Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision
Support interactions with Regulatory Agencies as required
May aid in updating current procedures/processes or assist in creating new procedures/processes
Review and analyze data for trending purposes
Track metrics on process timeliness and effectiveness
Participate in Post-Market Compliance initiatives

Skills

FDA CFR 21 Part 803

MDR Reporting

MIR Reporting

Medical Device Regulations

Post-Market Surveillance

Complaint Handling

Regulatory Compliance

Quality Systems Regulations

MEDDEV 2.12-1

Adverse Event Reporting

Risk Assessment

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.

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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