Senior Regulatory Affairs Specialist (12 Month Contract)

About Convatec

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 more than 10,000 colleagues, we provide our products and services in around 90 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. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

Position Overview

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 Responsibilities:

• Preparation and submission of regulatory dossiers (US FDA 510(k) submissions; EU CE Marking and UKCA Technical Documentation), and interface with authroities during the review process;

• 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;

• Provide regulatory support to enquiries from customers and authorities;

• Provide guidance to business partners and junior staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes. Support 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;

• Support 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;

• Participation as an active member of Industry, Regulatory or Scientific Committees as appropriate;

• Perform other duties as assigned.

Skills & Experience:

• 2+ years relevant experience, preferably in a Regulatory Affairs role in the life science industry

• Experience dealing directly with Notified Bodies, Competent Authorities, and/or US FDA

• Hands on experience of creating documentation compliant with FDA CFR 820 and EU Medical Devices Regulation EU MDR 2017/745 required

• Experience of 510(k) submissions desirable

• Preparation and submission of EU technical documentation

• Experience of regulatory requirements for medical devices containing animal derived materials

• Knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971

• Demonstrate excellent communication skills

• Demonstrate strong organizational skills, including the ability to prioritize workload

• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial

Qualifications/Education:

• Level of education required to have been achieved - Life Science Degree level or equivalent or equivalent or relevant experience in industry in lieu of degree.

• RAPS Certification preferred

Travel Requirements:

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

Working Conditions:

• This position is remote based, with occasional travel to the office. The office location for this role is Deeside (UK).

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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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