Principal Specialist Regulatory Affairs at Vontive

Rome, Lazio, Italy

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, Kidney CareIndustries

Requirements

Degree in engineering or life sciences
Around 3-5 years of experience preferably in Regulatory Affairs, Quality Assurance, R&D or System, Standard Compliance testing in a Medtech company/Notified Body or Regulatory Authority
Good knowledge of CE marking of medical devices (MDD 93/42/EEC, MDR 2017/745 and related directives and guidelines)
Ability to interpret European regulations and guidelines and all technical product information in order to assure that regulatory requirements in the area of medical devices are continuously met
Ability to liaise with the different functions involved in the elaboration of CE files, Manufacturing, Quality Assurance, R&D, Medical Affairs, Logistics
Excellent interpersonal and collaboration skills and willingness to work in a challenging regulatory environment
Excellent organizational skills including project management skills
Strong commitment to teamwork, quality and customer satisfaction
Excellent written and verbal communication skills in English
Cultural sensitivity
Accountable for anticipating and resolving problems
Open to innovation and risk taking

Responsibilities

Supports Vantive Legal Manufacturers in the fulfilment of regulatory responsibilities under the MDD and MDR
Provides direction to all Vantive legal manufacturers with regards to CE marking requirements
Interprets existing, pending and proposed regulations/guidance documents regarding MDD, MDR providing assessment on impact to Vantive
Works with cross-functional groups to ensure the development of regulatory strategies for the CE marking Medical Devices in accordance with the business goals
Collaborates with relevant teams to meet regulatory requirements related with data necessary for regulatory databases
Supports the implementation of the Regulatory Affairs management systems (including relevant SOPs) to ensure the regulatory requirements are met
Participate in regional Industry Association meetings (including MedTech EU working groups)
Leads CE marking related regulatory activities in front of the Notified Bodies and relevant Competent Authorities
Maintains compliance with regulatory requirements and internal policies and coordinates regulatory compliance activities

Skills

Key technologies and capabilities for this role

CE MarkingMDD 93/42/EECMDR 2017/745Regulatory ComplianceMedical DevicesRegulatory StrategyRegulatory AffairsSOPsRegulatory Databases

Questions & Answers

Common questions about this position

What experience is required for the Principal Specialist Regulatory Affairs role?

Around 3-5 years of experience preferably in Regulatory Affairs, Quality Assurance, R&D or System, Standard Compliance testing in a Medtech company/Notified Body or Regulatory Authority is required.

What specific knowledge is needed for CE marking in this position?

Good knowledge of CE marking of medical devices (MDD 93/42/EEC, MDR 2017/745 and related directives and guidelines) is required.

What is the salary range for this role?

This information is not specified in the job description.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What does Vantive's company culture emphasize?

Vantive emphasizes a community of focused, courageous people who don't settle for the mediocre and are driven to improve patients’ lives worldwide through innovations in vital organ therapies.

Vontive

Provides investment property mortgage solutions

About Vontive

Vontive provides investment property mortgages using technology to simplify and speed up the loan process. Their main product is a "bolt-on" technology that allows retail brands to easily launch their own mortgage services without needing programming skills. This no-code solution can be set up in just a few weeks, making it quicker for brands to offer mortgages. Vontive stands out from competitors by acting as a bridge between real estate investors, lenders, and capital providers, charging fees for their services that reduce traditional risks and inefficiencies in real estate financing. The company's goal is to modernize the investment real estate market by making the mortgage process more efficient and transparent for both retail brands and financial institutions.

San Francisco, CaliforniaHeadquarters

2017Year Founded

$32.1MTotal Funding

DEBTCompany Stage

Financial Services, Real EstateIndustries

11-50Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

Short- and Long-term Disability Coverage

Life Insurance

Wellness Program

Risks

Increased competition from fintech companies could erode Vontive's market share.

Potential regulatory scrutiny may lead to higher compliance costs and challenges.

Economic downturns could impact demand for investment property mortgages.

Differentiation

Vontive offers a no-code, white-label mortgage solution for real estate investors.

The platform integrates financial institutions through a unique debt marketplace.

Founded by industry veterans, Vontive leverages decades of mortgage and financial expertise.

Upsides

Vontive ranked #10 on the 2022 Deloitte Technology Fast 500 with 9,154% growth.

The company has financed over $1.1 billion in residential properties since April 2022.

Vontive's B2C ecosystem reaches over 1.5 million real estate investors.

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