Group Regulatory Affairs Specialist Class II (m/f/d)

Ontex DE; Großpostwitz/Oberlausitz; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading hygiene solutions provider is seeking a Group Regulatory Affairs Specialist Class II to join their Quality team in Großpostwitz. This role involves ensuring product compliance through regulatory frameworks, evaluating documentation for regulatory filings, and collaborating with cross-functional teams. A Master’s degree in science and a minimum of 3 years of experience in Regulatory Affairs for medical devices are required. Attractive remuneration, social benefits, and a permanent employment contract await the right candidate.

Leistungen

Holiday and Christmas bonuses

30 days of holiday

Company pension scheme

Corporate benefits and discounts

Qualifikationen

• Master’s degree or equivalent experience in science.
• Minimum of 3 years experience in Regulatory Affairs for medical devices.
• Fluent in English; knowledge of other languages is a plus.

Aufgaben

• Research and determine regulatory requirements for compliance.
• Evaluate documents for regulatory filings and provide guidance.
• Notify regulatory authorities of product safety issues.

Kenntnisse

Regulatory Affairs

Cross-functional collaboration

Communication

Regulatory submission experience

Knowledge of quality management systems

Ausbildung

Master’s degree in science

Tools

ISO 13485

Jobbeschreibung

Group Regulatory Affairs Specialist Class II (m/f/d)

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.

Your responsibilities:

1. Regulatory Frameworks and Strategy:

• 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 (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 offers 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 a future‑proof company bound by collective agreements
• Attractive remuneration and comprehensive social benefits, e.g.:
  • Holiday and Christmas bonuses
  • 30 days of holiday
  • Company pension scheme
  • Corporate benefits and discounts
• Exciting and varied working environment

If you're passionate about the role and believe you would be a great fit, we'd love to hear from you. We welcome candidates from all backgrounds to apply, ensuring a fair and transparent selection process. Should you have any questions, feel free to contact our HR department at [e-mail]