Regulatory Affairs Ops Specialist Senior

Do you want to contribute to a top quality medical research? We are searching for a candidate that wants to work for a global meditech company in Lund that touches the lives of millions of people around the world every day.

About the position
Under limited supervision you will be responsible for the implementation of regulatory strategies, and resolution of issues pertaining to documents/ packages for regulatory submissions. You will also be involved in produces and evaluates technical and scientific data necessary for regulatory submissions. Assists in the implementation and delivery of new or upgraded systems and processes in support of companies products.

Responsibilities
- Document all system related issues, and identify resolutions
- Document complex processes and create and manage documentation related to validated systems
- Participate in identifying solution to meet requirements for systems
- Participate in system upgrades to assure integrity of data is maintained
- Assure adequate access and functioning of system tools and version upgrades
- Provides expertise in ongoing maintenance of electronic record receipt and submission to regulatory authorities
- Participate as an active team member and provide expertise to project teams as required
- May verify the maintenance of support systems, libraries and dictionaries
- Maintain awareness of regulatory requirements and evaluate potential impact to company


Your profile
- Bachelor's Degree or country equivalent with a minimum of 5 years in a regulated environment. Scientific or related discipline would be an advantage.

- Detail oriented
- Technical system skills (e.g. word processing, spreadsheets, databases, online research)
- Written and verbal communication skills
- Knowledge of applicable regulations
- Excellent organizational skills and ability to support multiple projects
- Ability to contribute to multiple projects from an operations perspective
- Work independently with minimal direct supervision
- Strong negotiation and collaboration skills
- Manage multiple projects and deadlines
- Ability to identify compliance risks and resolve or escalate when necessary
- Experience in addressing complex problems or processes




About the organisation
This is an consultant assignment at our customer in Lund for six months with possibility of extension. During this time you will be hired by QRIOS.

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.