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- Tasks: Join our Regulatory Affairs team to ensure product compliance and registration across global markets.
- Company: Convatec is a leading global medical products company dedicated to improving lives through innovative solutions.
- Benefits: Enjoy flexible working options, a supportive culture, and opportunities for personal development.
- Why this job: Make a real impact in healthcare while collaborating with a dynamic team in a fast-paced environment.
- Qualifications: Ideal candidates have a relevant degree and knowledge of regulatory requirements in the medical field.
- Other info: This entry-level role offers a chance to grow within a FTSE 100 company.
The predicted salary is between 30000 - 42000 £ per year.
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.
Convatec Infusion Care is currently looking for a new colleague to join our dedicated Regulatory Affairs team. The RA department is responsible for Convatec Infusion Care product portfolio registration efforts and for ensuring local and worldwide regulatory compliance. You will be a part of a team of highly qualified and goal-oriented specialists who constantly aim at knowledge sharing, a high level of professionalism, and continuous improvement. While we set high standards for our work, we also strive for a healthy work-life balance and personal development.
Key Duties And Responsibilities:
- Correspond with customers, appointed representatives in different countries and authorities regarding product registration;
- Ensure that registrations fulfill regulatory requirements in relevant markets;
- Maintain competence and knowledge regarding product registration and regulatory requirements in relevant markets ensuring that the impact of new regulations and changes in regulations are assessed and communicated within the organization, as required;
- Obtain knowledge of regulatory requirements to develop regulatory strategies for product launch and support registration in new markets;
- Provide regulatory support across the organization to ensure that the regulatory requirements are met, and that relevant product documentation is in place as required by regulatory authorities during the different stages of the product life cycle;
- Ensure that documents are generated and maintained for the registration of new devices, changes to existing products, and notification of said changes to the regulatory authorities;
- Ensure maintenance of procedures and instructions related to Regulatory Affairs;
- Maintain regulatory Information in relevant databases;
- Ad hoc assistance within the regulatory field;
- Assess regulatory impact for changes to existing as well as new products;
- Sign documents related to products registration, according to the relevant procedures governing each document;
- Prepare, review, and sign Regulatory Assessment Plans.
About You:
We are looking for a structured, positive, and team-oriented specialist. Additionally, you possess excellent communication and project management skills, along with comprehensive knowledge of worldwide regulations and MDR. You understand that the key contributing factor to success is collaboration with your closest colleagues and across functions. Delivering high-quality, timely solutions, and projects are top priorities for you.
Your Qualifications And Experience:
- Engineer or technical/bachelor degree as Pharmaconomist, Laboratory technician, or relevant work experience (required);
- Customer service experience (preferred);
- Work experience with product registration/market access of medical devices or pharmaceuticals (preferred);
- Fluent English, verbal and written (required);
- Familiar with commonly used computer software packages;
- Knowledge of regulations related to product registration (required);
- Knowledge of ISO 13485 or similar regulations (preferred).
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.
Regulatory Affairs Specialist employer: ConvaTec Group
Contact Detail:
ConvaTec Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements for medical devices in the markets you are interested in. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who work in medical devices. Attend industry conferences or webinars to gain insights and make connections that could lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in regulations related to medical devices. This knowledge can be a great conversation starter during interviews and shows your proactive approach to professional development.
✨Tip Number 4
Prepare to discuss your experience with project management and teamwork, as these skills are crucial for the Regulatory Affairs Specialist role. Think of examples where you've successfully collaborated on projects or navigated complex regulatory challenges.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Regulatory Affairs Specialist position at Convatec. Tailor your application to highlight how your skills and experiences align with these requirements.
Craft a Strong CV: Your CV should clearly outline your relevant experience, particularly in regulatory affairs or product registration. Use bullet points to detail your achievements and responsibilities in previous roles, focusing on those that relate to medical devices or pharmaceuticals.
Write a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Highlight specific experiences that demonstrate your knowledge of regulatory requirements and your ability to work collaboratively within teams. Make sure to convey your passion for improving patient outcomes.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs. Consider asking a friend or colleague to review it as well.
How to prepare for a job interview at ConvaTec Group
✨Understand Regulatory Requirements
Familiarise yourself with the specific regulatory requirements relevant to the medical devices and pharmaceuticals sector. Being able to discuss these regulations confidently will demonstrate your expertise and preparedness for the role.
✨Showcase Your Communication Skills
As a Regulatory Affairs Specialist, you'll need to communicate effectively with various stakeholders. Prepare examples of how you've successfully communicated complex information in previous roles, highlighting your ability to collaborate across teams.
✨Demonstrate Project Management Experience
Be ready to discuss your project management skills, especially in relation to managing multiple tasks simultaneously. Share specific instances where you successfully led projects or initiatives, focusing on your organisational skills and attention to detail.
✨Prepare Questions About the Company
Research Convatec and prepare insightful questions about their products, values, and future goals. This shows your genuine interest in the company and helps you assess if it's the right fit for you.
