Stryker RAQA Specialist in Malmo, Sweden
Requisition ID 22681BR
Job Title RAQA Specialist
Group Global Quality and Ops
Division European Business Operations
Business Function Regulatory Affairs
Employment Category Full Time
Percent Travel Required Up to 10%
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
Key Activities & Accountabilities:
We are seeking a RAQA Specialist to provide day to day regulatory support for all post market activities across the Nordic region. The position can be based in either the Swedish distribution site in Malmo, Sweden (preferable) or the Stryker office in Helsinki, Finland.
(Note: In addition to these activities employees are required to carry out such other duties as may reasonably be required)
Ensure Stryker Nordic (Sweden, Norway, Denmark, Finland, Iceland) meet PMS and vigilance requirements as laid down in the Medical Device Directive and associated guidelines, in relation to (but not exclusively) customer complaints, product holds and product field actions.
Liaise with European RAQA Team and Manufacturing sites to expedite the timely closure of actions relating to above mentioned areas.
Ensure Stryker Nordic meet corporate RAQA metrics.
Key contact for communications with the Nordic Competent Authorities. Working with relevant parties to ensure timely response to requests for information/action.
Provide support and advice to all levels within Stryker Nordic on European / local regulatory requirements. E.g. Sales & Marketing, Tenders, Customer Services, Logistics
Provide training to all new starters on applicable regulatory legislation, standards, requirements and internal processes. Provide ongoing regulatory training to existing employees using such mediums as WebEx, face-to-face presentations at sales meetings etc.
Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings.
Maintain RAQA monitoring tools and provide statistics for weekly / monthly / annual / ad-hoc reporting.
Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments.
Collaborate with QA Manager UK & Benenord to ensure continued compliance of Stryker Nordic with ISO9001 standard through internal audit programme, distributor audits, supplier approval, process improvements and participation in external BSI audit.
Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for Corporate / European quality assurance efforts
Position in Structure:
Stand alone RAQA role for Stryker Nordic
Member of UK & Benenord RAQA Team reporting directly to RAQA Manager UK & Benenord
Equipment / Software Used:
Microsoft Outlook, Excel, Word, PowerPoint, Visio.
Oracle ERP System
Trackwise – used for complaint handling and monitoring of regulatory actions
ComplianceWire – online learning management system
Qualifications / Education Required:
Degree educated or equivalent
Scientific, Engineering or law background preferable (but not essential).
Minimum 1-2 years experience in Medical Device Regulatory Affairs
Knowledge of the Medical Devices Directive and associated local laws.
Knowledge of Quality Management System Standards preferred e.g. ISO9001, ISO13485
At least one Scandinavian language required, preferably Swedish
Fluent in English, both spoken and written.
Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
Excellent attention to detail and high degree of accuracy when analysing and compiling documentation / data
Able to handle multiple projects and exercise good judgment in prioritizing tasks.
Able to work to strict deadlines and under pressure.
Ability to influence and negotiate.
Ability to self-motivate in stand-alone RAQA role but also integrate as part of wider Stryker Nordic team
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