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Ontex Peninsular Logo Ontex Peninsular · IT - Administration

Group Regulatory Affairs Specialist Class II

Germany, Grosspostwitz Employment contract · Job Posted June 02, 2026
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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 to join our Quality team in Großpostwitz/Germany.

Job Responsibility

  • Researches and determines requirements for regulatory submissions, approval pathways and compliance activities
  • Monitor and evaluate the regulatory environment and provide internal advice
  • Supervises data input activities and provides impact analysis
  • Identifies the need for new regulatory procedures and SOPs
  • Identifies requirements for market access and distribution
  • Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
  • Actively contribute in assessing the impact of new guidance and regulations
  • Provides regulatory input and technical guidance on global regulatory requirements
  • 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
  • May identify, monitor, and submit relevant reports or notifications to regulatory authorities
  • Notifies organization and Regulatory Authorities regarding product safety issues
  • Provides regulatory input and support for inspections and audits
  • Submits notifiable changes and supplemental dossiers to regulatory authorities
  • Assures post market regulatory requirements are met
  • Continually improves the quality of policies, programs and services
  • Maintains knowledge of evolving regulatory information systems
  • Understands financial information used to make decisions and assists in developing budgets
  • Identifies vital resources and personnel for the project team
  • Tracks and assesses scientific and clinical advances
  • Participates in targeted education and evolving science study
  • 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
  • Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
  • 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

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

  • Permanent employment contract in a future-proof company bound by collective agreements
  • Attractive remuneration and comprehensive social benefits
  • Holiday and Christmas bonuses
  • 30 days of holiday
  • Company pension scheme
  • Corporate benefits and discounts
  • Exciting and varied working environment
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