Euro Diagnostica is a medical device company that produces and sells assays used in diagnosis of various human diseases and as a tool in drug development.
We are looking for a Regulatory Affairs Manager with a broad experience, preferably with experience from work within the medical device/in vitro diagnostic industry as well as the pharmaceutical industry.
The overall responsibility of the Regulatory Affairs Manager (RAM) is to strategically evaluate and implement regulatory initiatives for the company’s marketed products and provide input to future products. The Regulatory Affairs Manager is also responsible to implement and assure efficient regulatory processes and optimal regulatory submissions, as well as relevant maintenance activities, together with the Regulatory team.
Specific Responsibilities Include:
Overall responsibility for Euro Diagnostica regulatory compliance. Review, implement and verify compliance with applicable regulations.
Build, develop and lead a high performance RA team.
Develop, present and implement a world-class overall regulatory strategy through an optimal and lean system to support the business needs.
Ensure all RA activities and processes are coordinated and executed effectively and efficiently. Ensure compliance with all applicable policies and regulations.
Provide input and support to executive management on strategic, regulatory and operating issues. Create effective partnerships with peers, key stakeholders and regulatory bodies.
Provide input to the product development process. Support the design, development and commercialization of products. Work closely with R&D, Quality Assurance, Quality Control, Marketing, Sales, Manufacturing, Finance and Operations to achieve growth objectives.
Prepare, consolidate and review documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, supplements, pre-IDE, registrations at SFDA (China) and technical files for CE marking.
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Draft, consolidate and review instructions for use, product promotional materials and labelling for compliance with applicable regulations and policies.
Financial responsible for RA budget.
Master’s degree in a related field (e.g., biology, immunology, biochemistry, medical science, regulatory and quality assurance).
10+ years of Regulatory Management, including new technology, diagnostics reagents, system solutions for international business.
Successful track record in product registration in USA, Canada, Asia and Europe.
Current knowledge of FDA QSR 21 CFR 820, U.S. medical device and in vitro diagnostic regulatory requirements, MDD-, IVD- Directive/Regulation requirements, Canadian SOR/98-282 and relevant ISO standards. (Preferable also REACH/CLP, GMM, ABP, EUROATOM)
Knowledge & Skills: Your personal characteristics are very important and should include a thorough mind, problem solving abilities and good communication skills:
Ability to function in a responsible, professional manner using good judgment in decision-making.
Ability to tackle problems and take independent action, seek out new responsibilities, act on opportunities, generate new ideas, and practice self-development.
Work on complex assignments where considerable judgment and initiative are required in resolving problems and making recommendations. Prioritize tasks to accomplish goals and objectives. Good interpersonal skills combined with the ability to make an impact. Excellent intercultural skills.
Creative in guiding the regulatory processes structured at a professional level.
Ability to motivate, develop and manage an efficient regulatory organization.
Make decisions while considering both the needs of a global market and the sensitivities and requirements of local cultures.
Ability to simplify and process complex issues by implementing and following rational steps and procedures.
Proficient with Microsoft Office products (Excel, Word, PowerPoint ).
Fluent in Swedish and English (oral and in writing).
Ability to establish structured and logical work flows.
Can create and deliver accurate and punctual presentations in both written and oral formats (Scandinavian & English).
Requires the ability to think creatively and develop ideas outside traditional regulatory paradigms.
Drive continuous improvements.
Please apply by uploading your CV and cover letter. Please note that we do not accept applications by email. We will process the applications on an ongoing basis and call for interviews as soon as possible. Last day for application is September 30, 2016.
For further information about the position you are welcome to contact Maria Axelsson, Quality Assurance Director, on +46 (0) 40 53 76 30. Union representative (Unionen): Gunilla Jönsson, tel: +46 40 53 76 28, Union representative (Akademikerna) Elsa Grenmyr, +46 40-53 76 54.
About Euro Diagnostica
Euro Diagnostica facilitates the development of safe and efficient drugs and optimal treatment of patients by providing cutting edge assays. By offering versatile assay solutions to pharma, biotech and CRO customers Euro Diagnostica is an optimal partner in drug development from the exploratory phase to and beyond clinical trials. We also provide clinical labs and physicians with cutting-edge tools to aid in diagnosis, prognosis, monitoring and treatment of inflammatory and related diseases.
For more information please visit www.eurodiagnostica.com