BSc Science Jobs at Stryker Careers
Stryker, a global leader in medical technology, is hiring a Regulatory Reporting Specialist for its Joint Replacement Division based in Fort Lauderdale, Florida (Hybrid). In this role, youโll help ensure compliance with FDA, European, and international regulations related to adverse event reporting. Itโs a great opportunity for professionals eager to grow their careers in regulatory affairs and contribute to the quality and safety of life-changing medical devices. Apply for BSc Science Jobs at Stryker Careers. Join for Clinical Research Job and grow your career in regulatory affairs.
Job Details:
- Position: Regulatory Reporting Specialist
- Location: Fort Lauderdale, FL, 33301, USA
- Work Type: Hybrid or Onsite
- Department: RAQA (Regulatory Affairs & Quality Assurance)
- Req ID: R552619
- Employment Type: Full-Time
- Travel: Up to 10%
- Relocation: No
About the Company:
Stryker is one of the worldโs leading medical technology companies, committed to improving healthcare through innovative MedSurg, Neurotechnology, and Orthopaedics solutions. With a mission to make healthcare better, Stryker products and services help improve patient outcomes across more than 150 million patients annually worldwide.
Stryker is recognized for its award-winning culture, dedication to employee development, and a strong focus on quality, integrity, and innovation. Employees enjoy comprehensive benefits, professional growth opportunities, and the chance to make a meaningful impact on healthcare.
Educational Requirements for Regulatory Reporting Specialist Role:
- Bachelorโs degree (B.S. or B.A.) in Science, Engineering, or a related field.
- 0โ2 years of experience as a regulatory or quality professional in a regulated manufacturing environment.
Key Responsibilities of Regulatory Reporting Specialist:
- In this Clinical Research Job, you have to review and assess customer complaints for MDR/MIR reportability to FDA and European Competent Authorities.
- Ensure timely submission of initial and follow-up reports to regulatory agencies.
- Collaborate with Quality Complaint-Handling teams to ensure regulatory compliance.
- Support interactions with regulatory agencies when required.
- Contribute to updates or creation of procedures and processes related to compliance.
- Review and analyze complaint data for trend identification and reporting.
- Track metrics related to process timeliness and effectiveness.
- Participate in Post-Market Compliance initiatives to enhance quality systems.
Skills Required for the Regulatory Reporting Specialist:
- Strong understanding of FDA, EU, and global medical device regulations.
- Knowledge of CFR 21 Part 803 (MDR), CFR 21 Part 820 (QSR), ISO 13485, and MEDDEV 2.12-1.
- Analytical and data interpretation skills for trending and compliance reporting.
- Excellent cross-functional collaboration with departments such as Operations, Product Development, Marketing, and Quality.
- Strong organizational and time-management skills.
- Ability to manage multiple tasks efficiently under deadlines.
- Excellent written and verbal communication abilities.
How to Apply?
Interested candidates for the BSc Science Jobs can apply through Strykerโs official careers portal. To stay updated on similar regulatory and quality roles, you can set job alerts (weekly or daily) on Strykerโs career page.
