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Ontex Group NV
19d ago

Group Regulatory Affairs Specialist Class II(m/w/x)

Großpostwitz/O.L.
Full-timeOn-siteExperienced

Description

In this role, you will navigate the complex regulatory landscape, ensuring product compliance from development to post-market. You will collaborate with cross-functional teams, provide guidance on regulatory requirements, and stay updated on scientific advances that shape healthcare regulations.

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Requirements

  • Master’s degree in science or equivalent experience
  • In-depth knowledge of US and Canada regulations for medical devices
  • Knowledge of medical device regulations in Central America, South America (Brazil)
  • Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
  • Certifications in regulatory affairs like RAC
  • Fluency in English and any other language
  • Minimum of 3 years experience in Regulatory Affairs for medical devices
  • Experience in 510k submission
  • Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
  • Experience in working with cross-functional teams
  • Ability to integrate and demonstrate core values, integrity and accountability
  • Ability to lead, manage, collaborate and communicate within the organization

Education

Master's degree

Work Experience

3 years

Tasks

  • Research regulatory requirements for submissions and compliance
  • Monitor the regulatory environment and provide innovative advice
  • Supervise data input activities and analyze impact reports
  • Identify needs for new regulatory procedures and develop SOPs
  • Assess market access requirements and potential obstacles
  • Evaluate preclinical, clinical, and manufacturing documents
  • Provide regulatory input on global requirements to product teams
  • Advise stakeholders on regulatory requirements for quality data
  • Collaborate with cross-functional teams on regulatory interactions
  • Communicate with regulatory authorities during submissions
  • Submit relevant reports to regulatory authorities during research
  • Notify authorities about product safety issues for compliance
  • Support inspections and audits with regulatory input
  • Submit changes and updates to regulatory authorities
  • Ensure post-market regulatory requirements are met
  • Improve quality of policies and services provided
  • Maintain knowledge of evolving regulatory information systems
  • Assist in developing and monitoring departmental budgets
  • Identify vital resources for project teams
  • Track scientific advances impacting product development
  • Participate in education and studies to meet regulatory needs
  • Engage in stakeholder groups for science-based decision-making

Languages

EnglishBusiness Fluent

Benefits

Bonuses & Incentives

  • Holiday and Christmas bonuses

More Vacation Days

  • 30 days of holiday

Retirement Plans

  • Company pension scheme

Corporate Discounts

  • Corporate benefits and discounts

Diverse Work

  • Exciting and varied working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ontex Group NV and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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