The role as QA/RA Manager
We have a fantastic opportunity with a fast-expanding Medical Device company for a QA/RA Manager. Monivent has developed innovative technologies and require a QA/RA manager to join our growing team as we look to strengthen our QA/RA function. Do you have experience as a QA/RA Manager from MedTech and want the opportunity to make a real impact in your role? We are offering a challenging and independent key position in a friendly and engaging environment. You will become part of a fast-growing business with the mission of improving care for our youngest patients.
As our QA/RA Manager you will have a broad scoop of responsibilities, all of them related to the regulatory compliance. You are responsible for Monivent’s Quality Management System and need to make sure Monivent is compliant with the laws, regulations and standards for medical devices in various markets. You will also deliver solutions that aid compliance within the daily work of the organization.
You will establish and implement product registration strategies and plans for new markets and you will lead the work of getting product documentation in compliance with MDR. Deviation management, complaints, CAPA, internal/external audits and risk management are parts of your daily work. You will also handle registration, updates and re-registration of our products.
In this position you will keep contact with relevant competent authorities and Notified body, you will contribute in the post market surveillance and support colleagues in quality and regulatory requests, as the subject matter expert. Being part of a small company also calls for an operational (and truly flexible) mindset.
We are looking for someone with experience and knowledge from regulatory affairs, preferably in MedTech, and ISO 13485 and of MDD/MDR as well as FDA 510(k).
As a person, you are committed, independent and thorough with high integrity. You work in a structured and goal-oriented way. Good collaborative and communication skills are essential, as the role involves many internal and external contacts. Fluent in English is a prerequisite.
If you are outgoing and committed and appreciates the pace and the agile working style that a small scale-up company can offer you will enjoy working with us. Having a strong personal drive and at the same time being a true team player is the perfect combination when joining Monivent at this phase.
The QA/RA Manager reports directly to the CEO.
- Maintain the Quality Management system
- Communicate and maintain compliance in adherence to ISO 13485
- Lead the transition process from MDD to MDR
- Implement product registration strategies and plans for new markets
- Host regulatory agency audits (FDA, Notified Body, etc)
- Assist with the quality team activities
- BSc or MSc level in life science or engineering
- Experience in the field of quality and regulatory within medical devices
- Good understanding of ISO 13485 and of MDD/MDR
- Good understanding of FDA 510(k)
- Experience of leading registration processes in different markets
- Knowledge of flow measurement is a great advantage
- Excellent verbal and written communication and presentation skills in English
Professional and Personal Competences (Skills)
- Makes clear decisions, takes initiative, acts with confidence and works under own direction
- Sets clearly defined objectives, plans activities and projects well in advance. Monitors performance against deadlines and milestones.
- Writes in a clear and logical way, structures information to meet the needs and understanding of the intended audience
- Makes a strong personal impression on others, gains clear agreement and commitment by persuading, convincing and negotiating
- Strong team-building and collaborative skills
- Upholds ethics and values, follows procedures and policies
Opportunities with the role
Today Monivent consists of a few people, working closely together supporting each other in a friendly atmosphere and team spirit. This is an opportunity to work in a rapidly growing company listed on Spotlight Stock Market, with short decision-making processes where each employee’s contribution is important for the company’s development and results.
You will play an important role in actively supporting the company during an important journey with unique products for the benefit of patients (the small babies), parents and the healthcare system.
For inquires and more information about the position, please contact:
Eva Runnerström or Catharina Herbertsson, Sr Recruitment Consultants at PeakSearch (www.peaksearch.se).
firstname.lastname@example.org, +46 (0)701 725 379
email@example.com, +46 (0)706 152 772
Apply for the position at PeakSearch homepage www.peaksearch.se or send your cover letter together with your CV directly to either Catharina or Eva, see above.