Stryker Work From Home Jobs Advisor Full Time

Industry: Private
Employment Type: Full Time
Work Hours: 8
Salary: £35 – £45Hour
Location: United Kingdom
Company: Stryker

Description:

Stryker Work From Home Jobs Advisor Full Time

Who we want

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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.

Stryker Work From Home Jobs Advisor Full Time

What you will do:

The main objective of this role is to drive market access in Australia by providing technical support for the creation, review and finalisation of clinical evaluation documentation needed for the registration of medical devices in the Global market.

This role will work closely with Stryker Design Divisions and the Stryker South Pacific Regulatory and Market Access team to achieve this goal.

All aspects of the role must be in compliance with company policy as well as meeting internal and external customer demands.

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Key areas of accountability/responsibility:

Thorough understanding of the global Clinical Evidence requirements for regulatory compliance in the European and Australian market.
Understanding of Europe’s new Medical Devices Regulation (MDR 2017/745) and the US FDA regulatory pathways for medical devices.
Review analytical data from development studies and performance evaluation studies to ensure regulatory requirements are met.
Completely review all existing documentation in support of meeting the applicable Essential Principles of the Regulation(s). Evaluate and identify gaps or deficiencies in documentation.
Determine applicable testing requirements and standards for subject device.
Review available clinical data, compile a comprehensive and compliant Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary.
Compile and/or review proposed labelling and Instructions for Use.
Assess global regulatory requirements and make recommendations based specific regions to management to ensure technical documentation is compliant to introduce to global markets.

Stryker Work From Home Jobs Advisor Full Time

What You Need

Critical Requirements (eg: skills, experience, qualifications):

Skills:

A minimum of 3+ years demonstrated success in the analysis and interpretation of regulatory documentation and technical writing.
Thorough understanding of the requirements of the new European Medical Device Regulation (EU MDR) and some understanding of the Australian Medical Device Regulations.
Extensive experience in Medical Writing and preparation of Clinical Evaluation Reports (CERs)
Experience with preparing USA Premarket Notifications [510(k)s] (desirable)
Excellent communication skills

Qualifications:

Tertiary qualifications such as an undergraduate science or engineering degree or equivalent.

Stryker Work From Home Jobs Advisor Full Time

About the Stryker Company :

Stryker is a prominent medical technology company based in the United States, but it has a significant presence in the United Kingdom. Established in 1941 by Dr. Homer Stryker, an orthopedic surgeon, the company has grown into a global leader in medical technology, offering a wide range of innovative products and services in orthopedics, medical and surgical equipment, and neurotechnology and spine.

In the United Kingdom, Stryker operates through various facilities and offices, providing advanced medical solutions to improve patient care and outcomes. The company’s UK operations encompass the development, manufacturing, and distribution of medical devices and equipment, serving hospitals, surgical centers, and healthcare providers nationwide.

Stryker UK focuses on several key areas:

Orthopedics: Offering joint replacement implants, trauma products, and other orthopedic devices to help restore mobility and improve the quality of life for patients.
Medical and Surgical Equipment: Providing a wide range of products, including surgical instruments, endoscopic and communication systems, and patient care and handling equipment.
Neurotechnology and Spine: Developing advanced technologies for neurological procedures, including spine implants and minimally invasive surgery solutions.

The company’s commitment to innovation and quality has made it a trusted partner in the UK healthcare sector. Stryker’s UK division emphasizes collaboration with healthcare professionals to understand their needs and develop products that enhance patient care. This customer-centric approach, combined with a strong focus on research and development, ensures that Stryker remains at the forefront of medical technology in the UK.

Overall, Stryker’s presence in the United Kingdom highlights its dedication to improving healthcare outcomes through innovative medical solutions and strong partnerships with the medical community.

Stryker Work From Home Jobs Advisor Full Time

Stryker Work From Home Jobs Advisor Full Time – SarkariVaccancy

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