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 2023 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

Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as a Technical Project Manager, and you’ll do the same.

 

The role:

The primary responsibilities of the position are to ensure regulatory compliance of a defined group of Convatec products, drive regulatory processes and activities (such as regulatory strategy, product registration, change control, 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:

Advise on strategies and registration requirements for product development and marketed productsWrite and submit regulatory dossiers (e.g., US FDA submissions, EU CE marking and UKCA Technical Documentation), and interface with authorities during the review processLead regulatory assessment and actions for changes to product and QMS processesEnsure Regulatory compliance to maintain market approvalsFoster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorshipRegulatory support to enquiries from customers and authoritiesProvide 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 portfolioReview, interpret and communicate FDA/EU/international regulations and guidance documents to ensure complete and scientifically sound product submissionsSupport base business activities, such as Annual Reports, Supplements, Labeling reviews, UDIIdentify 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 proceduresSupports regulatory compliance to QSR, ISO, MDSAP, CE and other worldwide regulatory requirements as appropriate through customer complaints, internal and external audits, and training systemsRegulatory review and approval of documents supporting the QMS and product registrationsParticipates as an active member of Industry, Regulatory or Scientific Committees, as appropriateThis position serves as a delegate for the line manager stated on this job description

Authority (if applicable):

Regulatory approval of required documentation to support product development, registration and lifecycle management.

Skills & Experience:

Preferred 1-2 years relevant experience, preferably in a regulatory affairs role in the life science industryUnderstanding of the regulatory framework for medical devices.Understanding of the Quality System Regulations ISO 13485:2016 including preparation andimplementation of standard operating proceduresExperience with Class I, II, and III sterile medical devices.Preferred experience dealing directly with Notified Bodies, Competent Authorities, and/or the US FDAExperience with US/EU submissions preferred.Good time management and problem-solving skills.Strong interpersonal and collaborative skills.Ability to execute both reactively and proactively and in a timely manner.Ability to conduct thorough research of regulatory requirements and related issues to identify potentialsolutions and available options.Experience supporting change control and new product development projectsStrong analytical skills with good judgment-making capabilities.Demonstrated organizational skills.Strong oral and written communication skills.Proficiency with Microsoft Office (Excel, Word, PowerPoint), Adobe Acrobat, and Internet-basedregulatory resources, Trackwise, Documentum etc.

Qualifications/Education:

A minimum of a bachelor’s degree in Science, Engineering, Medical Technology, or Nurse required. An advanced degree and/or Regulatory Affairs Certification (RAC) is preferred.

Travel Requirements

• Not more than 25% of work time.

• There may be some business-related travel associated with this role dependent on project and / or local market and UK / US / EU 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).

 

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-ÁN1

#LI-Hybrid

#ForeverCaring

#ForeverConvatec

#WeAreConvatec

 

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 careers@Convatec.com.

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.

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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!