Tensive is a biomedical company that is developing an innovative scaffold aiming to improve breast cancer patients’ quality of life, by offering a natural breast reconstruction.
We are looking for a Regulatory Affairs Specialist (RAS) to work closely with our Quality Assurance & Regulatory Affairs (QA&RA) team in managing the regulatory affairs activities and executing our Quality Management System (QMS) in accordance with the requirements of ISO 13485:2016. The RAS will be also involved in project planning, writing and management related to Production and R&D activities of the company.
We love to hire collaborative and self-motivated people with a passion for learning and a teamwork spirit. Our team invests heavily in coaching new hires.
The RAS will directly be involved in the following activities as assigned by the CEO and CQA&RAO:
- Prepare, verify and update Regulatory Affairs documentation;
- Prepare, verify and update QMS documentation;
- Collaborate to the management of the relationship with competent authorities regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review;
- Interpret regulatory rules changes and ensure that they are communicated through corporate policies and procedures;
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation;
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues;
- Advise on types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or other changes;
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance;
- Develop or conduct employee regulatory and quality training;
- Collaborate to the management of internal and external audit;
- Observe the production process and suggest improvement plans with the goal to minimize errors and products’ defects or non-conformities (preventative actions);
- Propose corrective action plans in collaboration with CEO, CQA&RAO and CTO;
The successful candidate will work closely with the other members of the QA&RA team to ensure that all of the above-mentioned activities are completed according to Tensive’s implementation timeline.
- BSc, preferably in a management discipline or Industrial&Management Engineering;
- 1-3 years of relevant work experience within the area of Regulatory Affairs ands/or Quality Assurance;
- 1-3 years of work experience in multidisciplinary teams;
- Excellent knowledge of the Microsoft Office package;
- Proficiency in written and spoken English is required.
- Excellent interpersonal skills with the ability to interact and communicate effectively;
- Ability to independently organize his/her own schedule to achieve goals and meet projects and company deadlines;
- Excellent attitude to teamwork and ability to work in a small, fast-growing startup environment;
- Ability to manage stress during intense working periods;
- Problem solving and critical thinking skills.
- MSc, preferably in a management discipline or Industrial&Management Engineering;
- Relevant work experience abroad;
- Relevant work experience with an ISO certification body;
- Experience in medical device companies is preferred;
- Knowledge of and experience in Regulatory Affairs and QMSs (preferably within the medical device sector);
Preferred Technical Skills:
- Knowledge of validation processes for computer software used in QMSs;
- Competent with the language and writing style necessary for quality documents (such as those necessary for the drafting of standard operating procedures and work instructions).