Group Regulatory Affairs Specialist Class II Job at Ontex Peninsular (Grosspostwitz)

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

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Group Regulatory Affairs Specialist Class II

Job Description

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