Regulatory Affairs Specialist

Tensive

Milan, IT
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 04/20/2021
  • Website: tensivemed.com
  • Company Address: Via Timavo, 34 20124 Milano, Italy

About Tensive

Tensive is a biomedical company developing advanced biomaterials for regenerative medicine applications, with a current focus on reconstructive surgery after breast cancer. Our product has not yet been tested in humans.

Job Description

The Opportunity

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.

Responsibilities

The RAS will directly be involved in the following activities as assigned by the CEO and CQA&RAO:

  1. Prepare, verify and update Regulatory Affairs documentation;
  2. Prepare, verify and update QMS documentation;
  3. 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;
  4. Interpret regulatory rules changes and ensure that they are communicated through corporate policies and procedures;
  5. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation;
  6. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues;
  7. Advise on types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or other changes;
  8. Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance;
  9. Develop or conduct employee regulatory and quality training;
  10. Collaborate to the management of internal and external audit;
  11. Observe the production process and suggest improvement plans with the goal to minimize errors and products’ defects or non-conformities (preventative actions);
  12. 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.

Minimum Qualifications: 

  • 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.

 

Soft Skills: 

  • 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.

 

Preferred Requirements:

  • 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).

 

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.