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Senior Regulatory Affairs Specialist

Location: Deeside
Company: ConvaTec
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At ConvaTec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We are a global medical technology business focused on serving people and care givers in the areas of advanced wound care, ostomy care, continence and critical care and infusion care. We devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom and mobility. We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What's Right. We are a global Group, with over 9,900 employees and in 2020, our Group generated revenues of over $1.894 billion. To learn more about ConvaTec, please visit www.convatecgroup.com.
About the role:
- As Senior Regulatory Affairs Specialist you will be operating as a medical device regulatory resource for Sustaining Engineering.
- The primary responsibilities of the position are to ensure regulatory compliance of defined ConvaTec products globally, drive regulatory processes and activities (such as change control) and continue to develop strong working relationships with internal and external customers.
- You will also be responsible for the management of global and regional regulatory projects, including, but not exclusively, product life cycle and regulatory processes within the Sustaining Engineering function.
- Creation, development and maintenance of high quality regulatory compliant documentation, especially for Class II/Unclassified products for the US market.
- For medical device products under development liaise with Project Development teams to ensure regional RA requirements are included in the project plan and prepare the pre-marketing documentation e.g. for CE marking and 510k according to the agreed timeline
- Builds relationships and negotiates with relevant regulatory bodies on matters related to compliance of existing products and products undergoing development
- Creating new and innovative ways of doing things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.
- Assisting with global regulatory processes, such as Change Control, GMDN, etc
About you:
- Level of education required to have been achieved - Life Science Degree level or equivalent
- Demonstrated Regulatory/Quality experience in medical devices, specifically with class IIA devices
- Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA
- Hands on experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC; Medical Devices Regulation 2017/745
- Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971
- Demonstrate excellent communication skills
- Demonstrate strong organisational skills, including the ability to prioritise workload
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial
Working Conditions:.
- This position is remote based with one visit per month at Deeside GDC as per business needs.
Special Factors:
- There may be rare instances whereby an employee may be required to work outside of non-core hours/days. This may be due to an unexpected event, crisis or project timeline pressure as may occur within the regulatory affairs industry.
What is great about being part of ConvaTec?
- ConvaTec environment is fully focused on a company mission which is based on creating an incredibly valuable patient-oriented organisation which enables us to become the market leader by offering high value products to our customers.
- As a ConvaTec employee you will become a part of fast-paced medical devices sector with a spotlight on making people's lives better.
- You will have access to series of training and personal development opportunities.
#LI-DS1
ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives: ConvaTec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any ConvaTec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
If you are an active employee at ConvaTec, please do not apply here. Go to the Career Worklet on your Workday home page and View "ConvaTec Internal Career Site - Find Jobs". Thank you!
ConvaTec is changing. We're transforming our business, fueled by a fierce determination to improve the lives of millions more customers around the world.
Our shared focus, and the sheer drive of our people, are giving us real momentum. They're also making us a uniquely invigorating place to work. Join us and, whatever your role, you'll be pushed and challenged every day. You'll be supported too, empowered to spark and drive change where it matters most.
We have a uniquely dynamic, sometimes demanding environment. But if you're motivated, and as focused on delivering for patients as we are, it'll bring the very best out in you. You'll never stand still. And you might just make the biggest impact of your entire career.
If you would like to know how we intend to use your data following your application please refer to our full data privacy policy on the following link: https://www.convatecgroup.com/privacy-policy/
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