20 annunci per il ruolo di area specialist - roma, laz (recruiting in corso)

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Senior Regulatory Affairs Specialist

Cosmo Pharmaceuticals
Roma, Lazio

Candidati adesso

Dettagli della posizione

Qualifiche

Medicina
Dottorato di ricerca
Inglese
Competenze analitiche
Laurea triennale
Intelligenza artificiale

Descrizione completa della posizione

PURPOSE

MedTech AI - Quality Assurance, MedTech AI - Regulatory Affairs

LOCATION

Rome

Description

The Senior Regulatory Affairs Specialist will be member of the Regulatory Affairs department, cooperating in all aspects of the activities related to compliance with applicable regulations, jurisdictions, guidelines and standards with specific expertise and focus on vigilance and reporting requirements and periodic updates analyses.

KEY RESPONSIBILITIES

Assess medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports. Review and provide input on mitigations, labeling and training materials, adverse events, complaints, incidents, and trends.
Manage and document post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with safety data, trend analysis.
Manage vigilance reporting to Competent Authorities and other stakeholders according to country requirements and assess failure investigations from the regulatory viewpoint.
Work with customers/users to gather information/data to support investigations and complaints management.
Monitor external sources/trends on emerging issues, including complaints, MDR trends, and regulatory trends, literature and scientific publications.
Transfer the regulatory compliance aspects during the design and development stage of products and act as contact point across the company functional areas.
Act as department representative during audits and other regulatory body interactions in the field of vigilance and post-market surveillance.
Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect.
Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape.
Promote the culture of compliance by proactively interacting with all departments and by provision of trainings.
Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities.

QUALIFICATIONS, SKILLS AND ABILITIES

Bachelor's degree in medicine, pharmacology, biomedical science or related scientific discipline, or equivalent. Higher degree/PhD will be an advantage.
Minimum of 5 years of experience in the regulatory affairs field in medical device industry of which minimum of 2 years of experience in vigilance reporting according to 21 CFR Part 803 in U.S and to MDD/MDR requirements in EU.
English proficiency at professional level
Deep knowledge and operative understanding of Reg. (EU) 2017/745 and MDCG documents, Title 21 CFR parts 800-898, and technical standards such as ISO 13485, ISO 14971, ISO/TR 20416, ISO 62304.
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy.
Basic knowledge of Reg. (EU) 2024/1689.

OTHER REQUIREMENTS

Strong analytical skills with a detail-oriented approach.
Ability to work independently and collaboratively across multifunctional teams.
Highly dynamic and adaptable to a fast-moving and innovative environment.

APPLICATION

Email us with your CV, résumé or portfolio, and a cover letter explaining your motivation for applying. Please include the job title in your email subject line.

Please review our privacy notice for job applicants

Thanking you for your application and for sending your CV, pursuant to art. 13 and 14 of the General Data Protection Regulation (EU) 2016/679, we provide you with all the necessary information relating to the processing of your personal data. The processed data will be your personal data that you deem appropriate to include in your CV. We invite you not to provide in your CV Personal Data falling within the special category of Personal Data pursuant to art. 9 of EU Regulation no. 679/2016(such as, for example, racial or ethnic origin, political opinions, religious or philosophical beliefs, union membership, data relating to the person's health or sex life or sexual orientation). We therefore reserve the right to delete or make anonymous such data if it is entered anyway. We inform you that your personal data will be processed in order to carry out an objective assessment of your professional and personal requirements in relation to the possibility of hiring for an open position, or future contact in the event of the opening of new positions relating to your professional figure. In compliance with the Art. 6 of the Regulation, the Data Processing is necessary to take steps at the request of the data subject prior to entering into a contract. The personal data being processed are provided directly by you; during an interview, the Data Controller may collect further data, including particular data, collected directly from you or from other sources; personal data from public registers may also constitute processing, always for purposes connected with the correct management of the employment relationship; during the interview you will be given specific information. All the aforementioned data will be kept for a period of 1 year and only in the event of the establishment of the employment relationship will they be kept for the entire duration of the contract and in relation to the terms established by the relevant legal obligations. Without prejudice to communications made in compliance with legal obligations, all data collected and processed may be communicated to categories of subjects such as the personnel office, function or area managers, group companies and labor consultants. The rights enshrined in the Regulation (access, rectification, cancellation, restriction and opposition, portability, and the right to lodge a complaint with the Authority) may be exercised against the Data Controller by writing to the following e-mail address: [email protected] For more information, please view the complete privacy policy at the link: cosmohealthconfidence/privacy-policy

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