Job Description

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

Job Summary

The primary responsibilities of the position are to drive regulatory strategy and registration across global markets for a defined group of Convatec products, drive regulatory processes and activities (such as change control, review of labelling, review of marketing materials, etc) and continue to develop strong working relationships with internal and external customers. The person will be responsible for the management of global and regional regulatory projects, including, but not limited to, the regulatory aspects of new product development, product life cycle and changes to existing products.

Key Duties and Responsibilities

• Preparation and submission of submit regulatory dossiers (US FDA 510(k) submissions; EU CE marking and UKCA Technical Documentation including Class III devices), and interface with authorities during the review process for
• Advise on strategies and registration requirements for product development and marketed products.
• Lead regulatory assessment and actions for changes to product and QMS processes.
• Ensure Regulatory compliance to maintain market approvals.
• Foster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorship
• Regulatory support to enquiries from customers and authorities
• Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes. Supports both new product development and currently marketed product portfolio.
• Review, interpret and communicate FDA/EU/international regulations and guidance documents to ensure complete and scientifically sound product submissions.
• Support base business activities, such as Annual Reports, Supplements, Labeling reviews, UDI.
• Identify and support or lead process improvement projects to streamline current activities and increase department efficiencies, including the update, enhancement, creation of new internal policies and procedures, and maintenance of existing procedures.
• Supports regulatory compliance to QSR, ISO, MDSAP, CE and other worldwide regulatory requirements as appropriate through customer complaints, internal and external audits, and training systems.
• Regulatory review and approval of documents supporting the QMS and product registrations.
• Participates as an active member of Industry, Regulatory or Scientific Committees, as appropriate.
• This position serves as a delegate for the line manager stated on this job description.

Travel Requirements

There may be some business-related travel associated with this role dependent on 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.

Attendance of relevant training and development events would be required.

Some destinations may involve overnight stay(s).

About You

• Level of education required to have been achieved - Life Science Degree level or equivalent.
• RAPS Certification preferred.
• Regulatory/Quality experience in medical devices
• Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA
• Hands on experience of creating documentation compliant with FDA CFR 820 and EU Medical Devices Directive 93/42/EEC / EU MDR 2017/745:
• 510(k) submissions, 3-5 minimum
• Preparation and submission of EU technical documentation
• Experience of regulatory requirements for medical devices containing animal derived materials
• Experience of regulatory requirements for medical Devices with an Ancillary medicinal substance
• Knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971

Working Conditions

This position is hybrid with a minimum expectation to travel to the office in Deeside 1-2 days every other week.

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 transformation will change your career. For good. You\'ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you\'ll be supported to bring them to life. There\'ll be challenges. But stretch yourself and embrace the opportunities, and you could make your biggest impact yet.

This is stepping outside of your comfort zone.

This is work that\'ll move you.

#LI-LT2

#LI-Hybrid

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you\xe2\x80\x99re unsure, please contact us at .

Equal opportunities

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.

Already a Convatec employee?

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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