![Inspiration Healthcare Group](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Labelling Associate
1 week ago
Inspiration Healthcare is a British based, global provider of medical technology, and our mission is to pioneer medical technology that improves outcomes of patients, starting with the very first breaths of life.
We provide high-quality, innovative products to patients around the world that help to improve patient outcomes, and we actively invest in innovative product opportunities, disruptive technologies and, of course, our people.
The Group currently consists of three companies
:Inspiration Healthcare Ltd,
SLE Ltd and
Viomedex Ltd and, under these brands, we sell neonatal intensive care and operating theatre equipment around the world through a network of distributors into over 75 countries.
Products range from highly sophisticated capital equipment through to single-use disposables all of which can help improve outcomes of extremely sick patients.
We can proudly admit that we haven't come this far without entrepreneurial spirit, a solution driven attitude, and a determination to improve outcomes for premature and sick babies.
So if making a positive difference to other people's lives resonates with you and you believe that you have what it takes to flourish and succeed in this role, then we'd love to hear from you.
Position:
JOB PURPOSE (ROLE DEFINITION):
The Regulatory Affairs Labelling Associate is responsible for helping to produce and maintain high quality documents to support the portfolio of medical devices.
This position provides and contributes to the delivery of documents from User Manuals, Instructions for Use, Service Manuals and labels.
MAIN DUTIES AND RESPONSIBILITIES
- Work with internal teams to obtain an indepth understanding of the products and the documentation requirements;
- Produce high quality documentation and illustrations that comply to the applicable medical device;
- Manage the translation of documentation by collaborating with external translation services;
- Deploy documentation into various electronic formats;
- Adhere to the Company's Quality policy and objectives, and the requirements of the Company's Business Management System.
MANAGEMENT RESPONSIBILITIES
None
Requirements:
EXPERIENCE AND QUALIFICATIONS REQUIRED
Mandatory
- Experience with software programs such as InDesign and Illustrator, photoshop
- Proven working experience in Medical Device Manufacturing
KEY SKILLS AND COMPETENCIES
- Ability to deliver high quality documentation paying attention to detail within defined timescales;
- Ability to grasp complex technical concepts and make them easily understandable in text and pictures;
- Excellent written English skills;
- The ability to handle high volumes of work under pressure and in a multitask mode, prioritise duties and operate in an organised and diligent manner;
- A natural relationship builder and able to manage expectations in a personable manner;
- Able to quickly establish credibility and respect;
- Able to deal with individuals of all levels;
- The ability to work well as part of a team and equally well on your own and using your initiative;
- Handson, selfstarter, with a cando, flexible attitude and a determination to meet customer and Company needs.
Other information:
As well as being dedicated to providing a great place to work in a rewarding, stimulating and environmentally conscientious environment, we offer an extensive range of benefits, listed below, and actively support learning and development opportunities for all:
- 25 days' holiday pa, rising to 28, plus bank holidays
- Compressed 4 day week & blended working options
- Enhanced pension scheme (with salary sacrifice option)
- Bonus schemes
- Sharesave scheme
- Mind & body wellbeing support
- Healthcare cash plan
- Retailer discounts
- Life assurance
- Enhanced and equal leave & pay for new parents
- Cycle to Work
- SmartTech scheme
- Electric Car Benefit
- Employee referral scheme
- Travel season ticket loan
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