About the role:
Convatec Infusion Care is expanding and currently looking for a new colleague to join our Regulatory Affairs Department. The Regulatory Affairs Team, amongst other activities, is responsible for Convatec Infusion Care product portfolio registration efforts and for ensuring local and worldwide regulatory compliance. You will be part of an exciting and rewarding endeavor, where we build a team of highly qualified specialists with a strong focus on LEAN, knowledge sharing and continuous improvement. While aiming for the highest work standards, we strive for healthy work – life balance and personal and professional development.
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 managing global and regional regulatory projects, including the regulatory aspects of new product development, product life cycle and changes to existing products.
Your key responsibilities:
Advise on product development strategies and registration requirements.
Write and submit regulatory dossiers (, US FDA submissions, EU CE marking, UKCA Technical Documentation), and liaise with authorities during reviews.
Lead regulatory assessments and actions for product and QMS process changes.
Ensure regulatory compliance to maintain market approvals.
Foster regulatory knowledge and compliance through training and mentorship.
Provide regulatory support for customers and authority inquiries.
Guide business partners and junior staff on regulatory requirements, risks, and approval timelines for planning.
Review, interpret, and communicate regulations and guidance to ensure sound product submissions.
Support business activities such as Annual Reports, Supplements, Labeling reviews, UDI.
Lead or support process improvement projects to enhance department efficiency and update internal policies.
Ensure regulatory compliance with QSR, ISO, MDSAP, CE, and other requirements through audits and training.
Review and approve QMS and product registration documents.
Participate in Industry, Regulatory, or Scientific Committees as appropriate.
About You:
You are a structured, positive, and team-oriented senior specialist with project management skills and comprehensive knowledge of worldwide regulations and MDR. You excel at finding solutions, take pride in your expertise, and strive for continuous personal and professional improvement.
You value collaboration with colleagues across functions, delivering high-quality and timely solutions. Your approach includes good documentation practices, working methodically, knowing when to execute or delegate, and prioritizing effectively.
To succeed in this role, you should enjoy working within large project groups, managing multiple tasks simultaneously, and thriving in a busy environment. Fluency in English, both written and verbal, is essential, as it is the company language. You should also be flexible with working hours to accommodate meetings across different time zones.
Your Qualifications & Experience:
Master’s degree within Engineering, life science, pharmacy or similar.
Experience in the medical device industry and knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971.
Experience authoring and submitting medical device registrations/ licenses/submissions applicable to regional area.
Experience reviewing product labeling and advertising/promotional material for medical devices.
Experience with MDR/MDD and have preferablysubmitted a 510K.
Experience supporting change control and new product development projects.
About us:
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
Note: Please send your CV only in English language.
Convatec, Infusion Care (Unomedical a/s) is a part of a global medical technology business focused on serving people and care givers. We develop and market sterile disposable products for subcutaneous infusion of various medications. Specialized in the treatment of chronic diseases, such as Diabetes Mellitus and Parkinson’s Disease. Our manufacturing facilities in Denmark and Mexico produce more than 100 million infusion sets per year, making us the world leader within this field. Further information about the company can be found at our website or .
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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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