Regulatory Affairs Associate
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Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Regulatory Affairs Associate Nordics
At Alcon we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly champion progress and act with speed as the global leader in eye care. Here youll be recognized for your commitment and contributions and see your career like never before. Together we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse talented people to join Alcon.
As a Regulatory Affairs Associate Nordics supporting our Regulatory Affairs team you will be trusted to ensure regulatory compliance for Alcons medical device and pharmaceutical portfolio across the Nordic markets.
You will work closely with internal and external stakeholders to support submissions maintain product compliance and contribute to our mission of helping patients see brilliantly. This role is based in Copenhagen.
In this role a typical day will include:
- Regulatory Submissions Management - prepare compile and submit regulatory applicationsincluding registrations notifications variations - in line with EU MDR/IVDR requirements and local authority expectations.
- External Stakeholder Engagement - liaise with health authorities distributors and industry bodies to support regulatory activities address queries and foster strong professional relationships.
- Regulatory Strategy & Execution - support the development and execution of regulatory strategies for the Nordic region to ensure timely approvals and maintenance of regulatory dossiers in alignment with business needs.
- Compliance Oversight & Documentation - maintain product compliance by reviewing labeling materials promotional materials and documentation meet applicable regulatory standards; monitor regulatory changes and support implementation of new or updated requirements.
- Cross-functional Collaboration - partner closely with Quality Medical Affairs Commercial and Supply Chain teams to support product lifecycle management and provide regulatory guidance across the organization.
- Regulatory Intelligence & Training - track and analyze regulatory trends in the Nordics share insights with internal teams and assist in delivering training on regulatory processes requirements and best practices.
- Project Support & Continuous Improvement - contribute to regulatory aspects of new product introductions changes and portfolio optimization initiatives; support continuous improvement in regulatory processes and documentation quality.
WHAT YOULL BRING TO ALCON:
- Experience in Regulatory Affairs within the medical device and/or pharmaceutical industry ideally with exposure to EU MDR/IVDR.
- Understanding of Nordic (Danish Swedish Norwegian or Finnish) regulations on medical devices and pharmaceuticals.
- Fluency in English and proficiency in at least one Nordic language (Danish Swedish Norwegian or Finnish) is required.
- Education in Life Sciences Pharmacy or a related field would be preferable.
- Excellent organizational analytical and problemsolving skills with high attention to detail.
- Strong communication and interpersonal abilities to collaborate effectively in cross-functional settings.
- Ability to manage multiple projects simultaneously and deliver high-quality outputs within deadlines.
HOW YOU CAN THRIVE AT ALCON:
- Be part of a collaborative team that values innovation education and impact.
- You get the chance to help people see brilliantly. You will play a big part in making a difference in the lives of patients and be part of a company with a clear purpose cutting-edge innovation and breakthrough technology in eye care.
Alcon Careers
See your impact at Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.
