Regulatory Affairs Associate

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 and critical care, and infusion care. With around 10,000 colleagues, and a promise to be forever caring, our products and services are available in over 100 countries. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. The company is a constituent of the FTSE 100 Index (LSE: CTEC) and in 2021 revenues were over $2 billion.

**Job Summary**

Our successful Regulatory Affairs Associate will be required to ensure regulatory compliance of defined Convatec Advanced Wound Care products globally, supporting regulatory processes and activities (such as change control), developing strong working relationships with internal and external customers. The person will support the global regulatory affairs team with respect to global and regional regulatory projects, including, but not exclusively, product life cycle and regulatory processes. There will be a particular focus on developing strategies and document preparation for products marketed in global regions.

**Key Duties and Responsibilities**
- Creation, and maintenance of high quality regulatory compliant documentation, as needed for all classes of products per designated franchise responsibilities to ensure regulatory compliance and Pre-market clearances are achieved in a timely manner
- Provide regulatory support for products or processes undergoing change, liaising with Project Development teams, Project managers including but not limited to R&D, Marketing and Sales and Operations and other QARAC associates.
- Coordination and leadership of regulatory projects to support the regulatory department
- Support preparation and maintenance of technical documentation for all regions as designated e.g., for CE marking and 510k according to the agreed timeline
- Consistently build meaningful relationships and negotiate with key internal and external stakeholders
- Consistently drive to create and implement new and innovative ways of doing things.
- To assist with global regulatory processes, such as Change Control, GMDN, etc.

**Skills & Experience**
- Level of education required to have been achieved - Life Science Degree level or equivalent
- Demonstrate excellent communication skills
- Demonstrate strong organisational skills, including the ability to prioritise workload
- Strong interpersonal skills
- Regulatory/Quality experience in medical devices preferred
- Hands on experience of creating documentation compliant with EC Medical Devices Directive 93/42/EEC, Medical Device Regulation 2017/745, FDA CFR 820 and ISO 13485
- Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971 preferred
- Demonstrate the ability to deal effectively with a variety of personnel including but not limited to medical, scientific, manufacturing and commercial personnel.
- Demonstrate the ability to be flexible, open minded, and be able to adapt to a rapidly changing environment.

**Travel Requirements**
- This role will involve hybrid working with occasional travel where needed for team meetings/ work events.
- There may be some business-related travel associated with this role dependent on project and / or local market
- Attendance of relevant training and development events would be required.
- Some destinations may involve overnight or longer 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.

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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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