Senior Regulatory Affairs Specialist
Arjo AB Publ / Kemiingenjörsjobb / Malmö
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hela Sverige Visa alla jobb hos Arjo AB Publ i Malmö Key responsibilities
The Arjo Senior Regulatory Affairs Specialist participates in and supports new product development teams by assessing regulatory requirements required to achieve rapid market clearances and approvals also supporting modifications to existing products such as manufacturing processes, design, and materials. This position ensures that advertising and promotional activities are compliant with appropriate regulations and guidance along with participating in maintaining a strong working relationship with agencies, notified bodies, and organizations that govern products.
The role is based at Arjo Head Quarters in Malmö, Sweden. The role is global and requires international travel, approx. 20 %, based on project requirements. As Senior Regulatory Affairs Specialist you report into the Regulatory Compliance Manager.
Among your responsibilities will be to:
• Participate in establishing global regulatory strategies/ plans including development of documentation that lead to new product submissions in
support of global product marketing approvals.
• Participate on product development teams to develop global regulatory strategy and determine what regulatory submissions are required to market
the product globally.
• Assist in implementing manufacturing documentation for new products.
• Maintain open communications with FDA and other regulatory agencies.
• Prepare and file required documentation for tele communications regional agency requirements.
• With support from the Arjo team, interpret and utilize US and international medical device laws and regulations and provide regulatory advice
regarding global laws and regulations.
• Interpret and utilize tele communication laws and regulations and provide advice regarding global laws and regulations.
• Ensure that the product design and features meet regional confidentiality data requirements (such as patient identifiable data points).
• Interpret and utilize pertinent regional Cyber security requirements.
• With support from the Arjo team, review product labeling to assure published literature and labels are compliant with global labeling and marketing
regulations.
• Provide effective communication to project teams regarding new regulations, policies and initiatives that could impact products and processes.
Ideal candidate
• B.A. or B.S. degree is the minimum requirement with a major in a scientific discipline.
• 5 years regulatory experience in the medical device industry or applicable communications/tele
and 5 year's experience in QA/RA.
• Working knowledge of telecommunications and wireless (i.e. WiFi, BT, BLE, LTE) device regulations including but not limited to:
o US Federal Communications Commission (FCC)
o EU CE Marking (non-medical device)
o Canada Canadian Radio-television and Telecommunications Commission (CRTC)
o ETSI
• Working knowledge of specific standards such as:
o IEC 62304 Medical device software - Software life cycle processes
o IEC 60601 Medical Device Electric Safety Standards
o ANSI/AAMI EC13-2002 Cardiac monitors, heart rate meters, and alarms
o ISO 80601-2-61 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter
equipment
o UL 2900-1 Ed. 2017 Standard for Software Security Network-Connectable Products, Part 1: General Requirements, which includes evaluations and
assessments of network-connectable devices' cybersecurity vulnerabilities.
o AAMI TIR57: 2016 Principles for medical device security-Risk management
o 2014/53/EU Radio Equipment Directive (RED)
• Knowledge of Type Approval and Operator and MVNO approval processes
• Computer knowledge in Microsoft Word, Excel, Access, etc.
• Desirable: Working knowledge of global medical device regulations including Medical Devices Directive (MDD), European Medical Device Regulation
(EU MDR), FDA CFR among other region
regulations. Knowledge of WEEE and RoHS directives.
What We Consider As a Plus
Experience with telecommunications and wireless device regulations.
Sounds interesting?
Please, send your application, including CV, cover letter and other relevant document to us before 31 August. Applications will be evaluated on a continuous basis.
Together we can make a difference
Arjo is a global company with a Swedish heritage, where a thriving international environment is driven by Swedish culture. As a company that puts people at the heart of everything we do, Arjo employees are company partners supporting the mission to improve lives where they can explore challenging and rewarding careers in a wide range of specialties across the Arjo global network.
Publiceringsdatum2018-08-23Så ansöker duSista dag att ansöka är 2018-08-31
Klicka på denna länk för att göra din ansökanFöretagArjo AB Publ
AdressArjo AB Publ
Hans Michelsensgatan 10
21120 Malmö
KontorsadressHans Michelsensgatan 10
Jobbnummer 4307451
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