Job Information
Stryker Compliance Engineer, RAQA in Lund, Sweden
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
Compliance Engineer, RAQA
Welcome to join the Stryker/Jolife AB team in Lund where we develop and manufacture the LUCAS chest compression system; a life-saving medical device invented in Lund and used by emergency care professionals all over the world to treat sudden cardiac arrest patients.
In your new role as Compliance Engineer you will ensure the organization maintains regulatory compliance for the quality system and the device, including the product environmental aspects. You will be Responsible for the Circulatory Business Regulatory Intelligence and the management for the evaluation of new and revised international safety standards, regulations, and others from initiation to completion.
As the local Subject Matter Expert for the Product Environmental Compliance you will be responsible to define, develop, and deploy environmental strategies, programs and systems to comply with international product environmental regulations, customer expectations, and company policies, initiatives and goals.
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.
Is this you?
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 65
You have a Bachelor's Degree in Engineering, Science or other relevant field.
You speak Fluent Swedish and English A keypart of this role will be to work with international stakeholders across the world.
You are a Collaborative Partner with excellent interpersonal communication and collaborative teamwork skills, who thrives to work with team members at various levels of the organization and from different cultures.
You stay focused on the Goal You are self-directed and enjoys problem solving while staying focused on the goal. You can organize and understand the importance of keeping track of what is going on in your goals/projects.
You do the Right Thing You have a high level of integrity, responsibility, discipline, and attention to detail.
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
The Company
Jolife AB, a wholly owned company by Stryker Inc, develops and markets the LUCAS ™ Chest Compression System, with related accessories for the global market. LUCAS ™ is a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR).
Stryker Lund/Jolife AB is a part of Stryker corporation, an American global leading med tech company, listed on NYSE; a Fortune 500 company; with a solid track record of continuous growth and awarded for being a great place to work.
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spines that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more that 130 million patients annually. More information is available at stryker.com.
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. (http:)
Stryker Corporation is an equal opportunity employer. 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.