Stryker
Regulatory Reporting Specialist (Hybrid)
Join to apply for the
Regulatory Reporting Specialist (Hybrid)
role at
Stryker .
Stryker is currently seeking a
Regulatory Reporting Specialist
to join our Joint Replacement Division to be based hybrid in Weston, FL.
What You Will Do
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
Required
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 (International Organization for Standardization)
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
Benefits Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Seniority Level
Associate
Employment Type
Full-time
Job Function
Legal
Industries
Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Stryker by 2x
Get notified about new Regulatory Specialist jobs in
Fort Lauderdale, FL .
#J-18808-Ljbffr
Regulatory Reporting Specialist (Hybrid)
role at
Stryker .
Stryker is currently seeking a
Regulatory Reporting Specialist
to join our Joint Replacement Division to be based hybrid in Weston, FL.
What You Will Do
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
Required
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 (International Organization for Standardization)
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
Benefits Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Seniority Level
Associate
Employment Type
Full-time
Job Function
Legal
Industries
Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Stryker by 2x
Get notified about new Regulatory Specialist jobs in
Fort Lauderdale, FL .
#J-18808-Ljbffr