Regulatory Affairs Specialist

6 months ago

Deeside, United Kingdom ConvaTec Full time
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

Job Summary

The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting regulatory strategy and registration across global markets and across the whole Regulatory Affairs group. Individuals will be expected to help drive regulatory processes and activities (such as regulatory intelligence, global registrations, review of marketing materials, etc) and continue to develop strong working relationships with the rest of the RA group as well as 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

Generate and execute regulatory strategies for phased launches of newly developed products, changed devices and other major projects whilst liaising with and managing internal and external stakeholders to a defined timescale. Generate and approve regulatory technical documentation for various global markets in support of local regulatory and commercial activities. Request support for internal and external stakeholders across multiple processes including global regulatory activities such as Renewals, Re-registrations and Change submissions Support the business with the implementation and execution of a comprehensive regulatory intelligence system and supporting services. Encourage the improvement and alignment of processes across the Regulatory Affairs group. 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 Monthly Reports, master data management, portal/listing information, annual establishment reviews. 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 preferred 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 and global regulatory authorities. Preparation and submission of regional technical documentation supporting global registrations across multiple territories globally. Continuous improvement mindset with track record of implementing process improvements for regulatory affairs systems. Experience of regulatory requirements for medical devices containing animal derived materials preferred. Experience of regulatory requirements for medical Devices with an Ancillary medicinal substance preferred. 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-MF1

#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’re 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.

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