Regulatory Affairs Specialist

4 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).

**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 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 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 Devi

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