About the role:
In this position, you will operate as a medical device regulatory resource and expert for the Company and effectively deputise for the Regulatory Affairs Manager, as necessary.
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 be responsible for the management of global and regional regulatory projects, including, but not exclusively, product life cycle and regulatory processes. There will be a particular focus on developing strategies and document preparation for products marketed in the US or other regions as designated by Management.
Your key duties and responsibilities:
- To create and maintain high quality regulatory compliant documentation, as needed for all classes of products per designated franchise responsibilities to ensure Pre-market clearances are achieved in a timely manner.
- To act as a core team member for products under development liaising with Project Development teams, Project managers including but not limited to R&D, Marketing and Sales and Operations and other QARAC associates. This is to ensure all RA requirements are included in the project plan.
- To ensure timescales and regulatory pathways are fully understood and baked into the project plan and will be completed.
- To prepare the pre-marketing documentation for all regions as designated e.g. for CE marking and 510k according to the agreed timeline.
- To consistently build meaningful relationships and negotiate as needed with relevant regulatory bodies on matters related to compliance of products undergoing development.
- To consistently drive to create and implement new and innovative ways of doing things.
- To assist with global regulatory processes, such as Change Control, GMDN, etc.
Internal – Marketing, Operations, Regional Regulatory Affairs, R&D, Quality, Clinical. Leadership
External - Competent Authorities, Notified Bodies, other international government agencies
Travel Requirements: Yes
NMT 10% of work time. There may be some business-related travel associated with this role dependent on the project and/or local market and UK travel associated with this role because some team members are home-based and face-to-face contact with line manager and peers may be required. Focus on US regulatory matters may require US travel. Attendance of relevant training and development events would be required. Some destinations may involve overnight or longer stay(s). The ability to travel globally when required.
Language Skills Required:
- A degree in a Life Science related subject or equivalent experience in the life sciences industry.
- Regulatory/Quality experience in medical devices is required.
- Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA is required.
- Hands-on experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC is required.
- Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971 is required.
- You will demonstrate excellent communication and organizational skills, including the ability to prioritise your workload.
- You will demonstrate the ability to deal effectively with a variety of personnel including but not limited to medical, scientific, manufacturing and commercial personnel.
- You will demonstrate the ability to be flexible, open-minded, and be able to adapt to a rapidly changing environment.
This position is remote-based with monthly visits to the Deeside GDC facility.
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.
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
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!
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