Requisition ID 9542BR
Job Title Senior Staff Regulatory Compliance Specialist
Group Orthopaedics
Division Reconstructive
Business Unit RCNCQR
Business Function Regulatory Affairs
Country United States
State/Province NJ
City Mahwah
Employment Category Full Time
Percent Travel Required Up to 10%
Shift 1st
About Stryker Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Job Description / Information
The Senior Staff Regulatory Compliance Specialist ensures regulatory compliance by completing the appropriate filings and documentation pertaining to incidents of injury, product approval and product registration and recall as required by regulatory agencies. Responsible for performing activities associated with complaint file investigations and preparing files for closure, including inputs from production, change control, risk management and other departments as needed. Reviews complaints and develops procedures for complaint handling systems that are within FDA and ISO guidelines. Viewed as departmental resource.
General Responsibilities:
• Self-direct work under general supervision and instruction of more experienced staff
• Reports observations/ problems clearly and concisely and takes appropriate actions
• Demonstrates developing of advanced technical leadership skills within the department
• Possesses and applies a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
• Demonstrates strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities
• Demonstrates knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, post marketing compliance
• Plans, conducts and executes assignments, reviewing progress and evaluating results
• Recommends changes in procedures when indicated
• Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiencies
• Operates with appreciable latitude for independent action or decision, and reviews progress with management
• May direct work of Specialist or Sr. Specialist
• Assist Management in training RA Specialists & Sr. RA Specialists as required.
Tasks may include:
• Review complaints for adequate closure.
• Research potential injury liability issues.
• Decide when a nonconforming event has occurred and originate nonconformances into eCAPA system
• Communicate directly with customer and internal company resources to complete information needed for the complaint file.
• Monitor and facilitate product return for complaint investigation and analysis.
• Clarification of information provided during the Intake process to provide better clarity surrounding event descriptions
• Perform adverse event filings, including MDR and MDV reports.
• Utilize risk management process to determine potential and actual risk related to complaint events.
• Take lead on responses to additional information requests from Global Regulatory Agencies.
• Analyze complaint information to identify similar events or failure modes. Review data to identify adverse trends.
• Review and input into SOPs.
• Maintain compliance to regulations
• Provide input for product recalls and recall communications.
• Execute recall communications internally and externally.
• Witness destruction of nonconforming product
• Maintain quarantine of recalled or nonconforming product.
• Communicate with Global RA/QA on complaint investigation or recall instructions
• Track and report on recall progress and completion
• Directly correspond with regulatory agencies with minimal supervision.
• Provide regulatory compliance guidance and/or training to others.
• Perform internal regulatory and quality audits as assigned.
• Determine product failure root causes and evaluate risk of failures
• Investigate related failures, design, and manufacturing history of failed devices
• Determine trend results to input into post market product failure data
• Communicate with internal and external resources globally
• Ensure complaints are classified correctly and that all supporting data for investigations are adequately documented and attached to the complaint file
• Identifying product-associated problems and assist in developing proposals for solutions
• Assisting in SOP development and review
• Evaluating regulatory impact of proposed changes to launched products
• Monitoring impact of changing regulations
• Reviewing publicly disseminated information to minimize regulatory exposure
• Lead department initiatives and projects and participate divisional projects initiatives
• Communicate or facilitate communication of complaint investigation results to sales reps/customers
• Provide data and input into product design projects and regulatory submissions
• Responsible for providing communication to and from downstream product marketing on behalf of team
• Maintains product expertise related to specific assigned products to guide and coach others on team, including mechanical function of the product and clinical applications
• Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications
• Assisting in the development and implementation of SOPs and systems to track and manage product-associated events
• Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
• Review, approve and reject complaint investigations
• Approve regulatory filing decisions
• Develop, modify, and execute regulatory related company guidelines and procedures.
• Investigate department process nonconformances or potential nonconformances
• Assisting in the development and update of regulatory strategy based upon regulatory changes
• Providing regulatory input new product development and product lifecycle planning
• Reviewing regulatory aspects of contracts
Minimum Qualifications •BA/BS in Science, Engineering, Legal, or Regulatory Or relevant work experience (see below)
•5 + years of experience within medical device or other regulated industry
•Compliance leadership in providing guidance, training, and mentoring to less experienced colleagues and cross-functional team members.
•Extensive knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD) and MEDDEV guidance, and additional international regulations.
•Significant 510(k), IDE, PMA, CE Technical File/Design Dossier preparation, review, and submission experience.
•Significant experience interacting directly with FDA and Notified Body reviewers/inspectors.
•Understanding of the FDA device listing and establishment registration process.
•Demonstrated abilities and skills in the following key areas:
* Project management
* Risk-benefit analysis
* Analytical and writing skills
* Organizational and planning skills
* Advanced PC skills (MS Outlook, Word, PowerPoint, Excel)
* Interpersonal communication, collaborative team work, and negotiation skills
* Complying with constantly changing regulatory procedures; reprioritizing work effectively
* Identifying and correcting errors and inconsistencies (e.g. grammatical, contextual, etc.)
* Rapidly building product knowledge and understanding of highly technical and scientific regulatory activities
* Understanding and explaining detailed regulatory compliance programs and/or issues
* Analyze and resolve regulatory issues using independent judgment
* Communicate and network with regulatory personnel to obtain relevant information
* Work effectively with cross functional teams
* Plan and conduct meetings
* Negotiate internally and externally with Regulatory bodies