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Group Regulatory Affairs Specialist Class II

ontex.com Logo

Ontex Peninsular

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Location:
Germany , Grosspostwitz

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

At Ontex, we are making everyday life easier across generations. Worldwide our 5,500 colleagues are taking pride in their work, guided by our values – Passion, Reliability, Integrity, Drive and Everyone. Every day they are developing, producing, and distributing affordable and sustainable baby, woman and adult personal care products. As a leading international provider of personal hygiene solutions for retailer brands and healthcare partners, founded in Belgium in 1979 and listed on Euronext Brussels, we believe that innovation should be accessible to everyone. As we continue being 'Here for you’, we’re looking for a Group Regulatory Affairs Specialist Class II (m/f/d) to join our Quality team.

Job Responsibility:

  • Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities
  • Monitor and evaluate the regulatory environment and provide creative and innovative internal advice throughout the product lifecycle
  • Supervises data input activities and provides impact analysis and report conclusions and recommendations
  • Identifies the need for new regulatory procedures and SOPs
  • Identifies requirements and potential obstacles for market access and distribution
  • Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
  • Actively contribute in assessing the potential impact of new guidance and regulations on a regulatory filing
  • Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
  • Works with cross-functional teams for interactions with regulatory authorities
  • Provides regulatory information and guidance for proposed product claims/labelling
  • Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission
  • May identify, monitor, and submit relevant reports or notifications to regulatory authorities during the clinical research process
  • Notifies organization and as necessary Regulatory Authorities as required regarding product safety issues
  • Provides regulatory input and support and, as necessary, follow-up for inspections and audits
  • Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities
  • Assures post market regulatory requirements are met
  • Continually improves the quality of policies, programs and services provided
  • Maintains knowledge of evolving regulatory information systems and recommends potential applications
  • Understands financial information used to make department/unit and organization-wide decisions and assists in developing and monitoring department/unit budgets
  • Identifies vital resources and personnel for the project team internal and external to their direct area of responsibility
  • Tracks and assesses the scientific and clinical advances that impact healthcare product development and regulations
  • Participates in targeted education, clinical science, and evolving science study to meet regulatory requirements for emerging technologies
  • Participates in stakeholder groups to help shape science-based regulatory decision-making

Requirements:

  • Master’s degree (university or equal through experience) in science
  • In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
  • 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 and building strong relationships across departments
  • Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
  • Ability to lead, manage, collaborate and communicate within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession
  • Fluent in English

Nice to have:

  • Knowledge of medical device regulations in Central America, South America (Brazil)
  • Certifications in regulatory affairs like RAC
  • any other language
What we offer:
  • Holiday and Christmas bonuses
  • 30 days of holiday
  • Company pension scheme
  • Corporate benefits and discounts

Additional Information:

Job Posted:
January 20, 2026

Employment Type:
Fulltime
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