Regulatory Affairs Lead to global company

For our global costumer in Solna we’re now looking for a senior consultant in Regulatory Affairs.

About the position
In this position you'll:
• Oversee local company licenses and registrations of Medical Devices.
• Oversee local clinical trial registration of Medical Devices based on Franchise requests.
• Establish and maintain processes and procedures linked to Regulatory Affairs activities.
• Ensure all post marketing regulatory requirements are met, with an emphasis on ensuring all external communication/marketing materials are compliant with Region guidelines and restrictions.
• Establish and maintain a copy review process for marketing materials.
• Review and validate promotional materials (copy review for Medical Devices)
• Validate labelling and IFU of Medical Devices in local languages.
• Provide regulatory support (in collaboration with Franchises and EMEA/US Regulatory Affairs) to marketing, sales representatives, customers, customer service, tenders: communication of regulatory documents or information and answers to regulatory questions on products.
• Report updated local regulatory requirements and legislation to Management and Franchises, investigate and suggest solutions to resolve them.
• Perform regulatory training for MD marketing, MD sales representative and all other of the companie’s Medical Device relevant employees.
• Support compliance with applicable local directives and regulations (e.g WEE, Batteries, EMC, LVD, Packaging, RoHS, REACH)
• Nordic Representative in the EMEA RA Teams to ensure alignment of Nordic, Regional and Franchise goals.
• Represent the company in various internal and external forums as trade associations, meetings with local Health Authorities and local Competent Authorities.
• Liaison with local Competent Authorities.

Authorities
• Responsible for Nordic Regulatory Affairs compliance. Authorized to make decision in this area.
• Required to keep management updated.

Responsibilities
Key Relationships
• The Nordic Leadership team
• The Nordic organization
• EU Developed Market Teams
• EMEA RA Teams
• Franchises RA Teams
• Manufacturers RA Teams Key Skills Education & Qualifications
• Required education: University degree within one of the areas of pharmacy, medicine, engineering, or science.
• Languages: English and at least one of the Nordic languages.

Experience, skills and competencies (REQUIRED)
• Positive attitude, well organized with attention to details.
• Able to work independently with a high degree of integrity.
• Excellent written and verbal communication skills, presentation & negotiation skills.
• Able to work well with colleagues across multiple areas of the company and effectively interact with different internal stakeholders.
• Cultivate external relationships with regulators.
• Able to execute multiple tasks effectively across geographies and Franchises
• Live the credo in a way that creates a trusting, collaboratively and ethical work environment


About the organisation
QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles.

It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.


Kindly apply with your CV in English.
We look forward reading your application.