Group Regulatory Affairs Specialist Class II

Ontex DE; Großpostwitz/O.L.; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Holiday and Christmas bonuses

30 days of holiday

Company pension scheme

Corporate benefits and discounts

Zusammenfassung

Ontex DE in Großpostwitz/Germany is seeking a Group Regulatory Affairs Specialist Class II to join our Quality team. This role focuses on regulatory frameworks, product development, and postmarket activities for medical devices across US, Canada, and other regions.

You will lead regulatory strategy, supervise data input, collaborate with cross-functional teams, and ensure compliance throughout the product lifecycle. Advanced degree and RAC are assets; fluent English required.

Qualifikationen

• Master’s degree in science or equivalent.
• Extensive knowledge of US/Canada medical device regulations and guidance.
• Experience with regulatory submissions and product lifecycle oversight.
• Fluent in English; other languages assets.

Aufgaben

• Define regulatory frameworks and strategy for submissions and compliance.
• Support product development with regulatory input across lifecycle.
• Coordinate with authorities and manage postmarket notifications.
• Maintain SOPs and ensure market access objectives are met.
• Guide cross-functional teams on regulatory requirements.

Kenntnisse

Regulatory affairs

Medical devices

Regulatory strategy

Communication skills

Team leadership

Ausbildung

Master’s degree in science

RAC certification asset

Jobbeschreibung

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Group Regulatory Affairs Specialist Class II

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.

Your responsibilities:

1. Regulatory Frameworks and Strategy:

• Researches and determines requiremants (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 (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
• Supervises data input activities and provides impact analysis and report conclusions and recommendations.
• Identifies the need for new regulatory procedures and SOPs and assures that departmental SOPs are developed to ensure regulatory compliance and participate in development and implementation.
• Identifies requirements and potential obstacles for market access and distribution (federal, provincial/territorial state, reimbursement, purchasing groups, HTA, etc.) and the need for further regulatory guidance.

2. Product Development and Registration:

• Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing and offered plans/strategies (if appropriate) for changes that do not require submissions.
• Actively contribute in assessing the potential impact of new guidance and regulations on a regulatory filing and provides regulatory input and technical guidance on global regulatory requirements to product development teams.
• Advises stakeholders of regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
• 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 through appropriate communication tools.
• May identify, monitor, and submit relevant reports (e.g., Serious Adverse Events) or notifications (e.g., changes in manufacturing) to regulatory authorities during the clinical research process.

3. Postapproval/Postmarket:

• Notifies organization and as necessary Regulatory Authorities as required regarding product safety issues to ensure compliance with local, regional, and global regulations.
• 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 to update product information and instructions for use to reflect the current state of product knowledge.
• Assures post market regulatory requirements are met (e.g., required reports, maintains files on annual licenses, registrations and listings and other post marketing commitments).
• Continually improves the quality of policies, programs and services provided.
• Maintains knowledge of evolving regulatory information systems and recommends potential applications within the organization.
• 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.

5. Scientific and Health Concepts:

• 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.

Your profile:

Educational requirement:

• 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 medical device regulations in Central America, South America (Brazil) is an asset.
• Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971, …
• Certifications in regulatory affairs like RAC are an asset
• Fluent in English and any other language is considered an asset

Experience:

• 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

What you can expect:

• A permanent employment contract in an future‑proof company bound by collective agreements
• Attractive remuneration and comprehensive social benifits, e.g.:
  • Holiday and Christmas bonuses
  • 30 days of holiday
  • Company pension scheme
  • Corporate benefits and discounts
• Exciting and varied working environment

We welcome candidates from all backgrounds to apply, ensuring a fair and transparent selection process.