Compliance Engineer, RAQA

at  Stryker Corporation

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

OPPORTUNITIES & BENEFITS THAT THE ROLE OFFERS

• This person will be exposed to our passion to develop emergency care solutions that are designed to help save lives.
• Opportunity to work with fulfilling cross functional activities with colleague, both locally and internationally.
• Help shape the future of the LUCAS device to ensure we provide best in class products to our customers.
• Work in Europe’s 7th best “Great Place to Work”.
• Attractive flexibility in working arrangements.

WHAT WILL YOU DO AT STRYKER?

• Lead the identification, assessment, monitoring, and implementation of applicable new or revised standards, regulations, directives, implementing decisions and common specifications to assure postmarket regulatory requirements are met
• Evaluate the regulatory environment to assist in development of implementation strategies
• Work with individuals and department managers to identify appropriate resources and schedules needed for implementation actions
• Facilitate the Standard Review Board
• Design, implement, and maintain quality system procedures for product environmental compliance
• Plan, develop, implement, document, train, communicate and monitor compliance with international product environmental regulations and product compliance standards
• Assist the business and design teams in understanding environmental requirements and necessary actions to achieve compliance.
• Be responsible for verification that technical reports and required evidence documents exist at part and product level
• Oversee and / or execute submission of required reports to the regulating authorities

You have at least 4 years experience in the medical device, pharmaceutical or life science industry, preferably in a role where you have been exposed to applicable regulations, safety standards, product compliance and certifications. Product environmental compliance experience is a merit.

• Working knowledge with IEC standards for medical devices such as: IEC 60601 series / 62133-2 / IEC 62366-1 / ISO 14971 / ISO 13485
• Working knowledge with international regulations like: 21 CFR 820 / EU-MDR, RED / Low Voltage Directive 2014/35/EU (LVD) / SOR 98-282 / Australian Therapeutic Goods Act (TGA) / MHLW Ministerial Ordinance No. 169
• Working knowledge of regulations and best practices in the following areas: RoHS, REACH, WEEE, Battery, Packaging, and Proposition 6