Senior Regulatory Affairs Specialist
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.
- 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.
- 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.
- 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.
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