Senior Regulatory Compliance Specialist (R449272)
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. 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. We are currently seeking a Post Market Regulatory Compliance Specialist to join our Endoscopy division based in San Jose, California or Flower Mound, Texas.
Who we want
- Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
- Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do
Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Participates in good laboratory practices training of functional areas and assists in the development of training sessions. Ensures that privacy and security standards are met and adhered to. May coordinate activities and assist with interactions during regulatory agency inspections.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience
- Review complaints for adequate closure
- Research potential injury liability issues
- Customer follow up for missing information in complaint files and ensure product returns for 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.
- Work with senior staff to respond to additional Information requests from Global Regulatory Agencies.
- Review and input into standard operating procedures (SOPs)
- Maintain compliance to regulations
- Provide input for product recalls and recall communications.
- Execute recall communications internally and externally.
- Maintain quarantine of recalled or nonconforming product.
- Communicate with Global RAQA on complaint investigation or recall instructions.
- Track and report on recall progress and completion.
- Provide correspondence to regulatory agencies under close supervision.
- Provide regulatory compliance guidance and/or training to others.
- Perform internal regulatory and quality audits as assigned.
- 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.
What you need
- Bachelor’s degree
- Minimum of one year of relevant work experience preferred
- Previous Regulatory or Quality experience preferred
- 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), etc. preferred
- Experience with MDR/MDV reporting preferred
- Experience analyzing Medical Device complaints and reporting on adverse events preferred.
- Experience in technical/procedure writing is preferred
- Proficient with Microsoft Office and ability to learn Corporate systems required
- Ability to read and interpret Engineering schematics/drawings/prints is preferred
- Ability to understand and explain detailed regulatory compliance programs or issues
- Ability to comply with constantly changing regulatory procedures and prioritize work effectively
- Ability to analyze and resolve non-routine regulatory issues using independent judgment
- Demonstrated organizational, problem-solving, analytical and time management skills
- Demonstrated interpersonal skills required to interface with technical and non-technical personnel at all levels of the organization
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.