Regulatory Affairs Specialist - Medical (d/f/m)

Regulatory Affairs Specialist - Medical (d/f/m)

Bewerben

Remote type: Hybrid

Locations: Hamburg, Germany

Time type: Vollzeit

Posted on: Vor 4 Tagen

Job requisition ID: Essity250998

About Essity

Essity is a leading global hygiene and healthcare company. We are committed to improving the quality of life through high-quality hygiene and healthcare solutions. We sell our products and solutions in around 150 countries under many strong brands, including the global market leaders TENA and Tork, as well as well-known brands such as Jobst, Leukoplast, Libero, Libresse, Lotus, Nosotras, Saba, Tempo, Vinda and Zewa.

Your Role

• Develop and Implement Submission Strategies: Develop and implement submission strategies for the assigned product assortment of BSN Medical GmbH in alignment with relevant stakeholders in non-EU markets.

• Update Product Licenses and Processes: Keep product licenses and supporting processes updated with changes during product lifecycle management and changes in relevant regulations.

• Utilize Legal Knowledge: Utilize knowledge of national and international laws, regulations, guidance documents, and standards to shape and continuously improve regulatory documentation and registration activities.

• Ensure Regulatory Adherence: Ensure regulatory adherence in non-project-driven business processes such as marketing and sales, quality management, sourcing, and supply for global markets.

• Contribute to Regulatory Strategy: Contribute to the creation, implementation, and development of the regulatory strategy for global markets.

• Coordinate Communication: Coordinate communication necessary for product registrations with internal and external stakeholders, particularly regulatory authorities.

You Identify Yourself With

• Scientific or technical education/degree or equivalent professional experience (more than 3 years) in a regulated environment.

• Knowledge of regulatory affairs, preferably international registration requirements of medical devices.

• Proficiency in MS Office; SAP experience is an advantage.

• Thorough and structured working attitude.

• Ability to effectively work collaboratively in cross-functional teams, with intercultural competence.

• Fluency in written and spoken German and English.

Our Benefits for You

• Compensation & Benefits: Compensation according to the chemical tariff, yearly special payment, holiday allowance and bonus, pension schemes, anniversary bonus, child allowance, Corporate Benefits & other employee benefits.

• Work-Life-Balance: Hybrid working model, flexible working hours, overtime compensation, 37.5h week, 30 days of vacation, future amount (can be used as 5 days of vacation, Lease-a-bike or payout), lifetime working time account.

• Learning & Development: Structured onboarding, training opportunities such as digital learning platform, coaching & mentoring as possible part of individual development plan, participation in professional conferences and fairs.

• Health & Well-being: Discounted fitness membership, Urban Sports Club, health and well-being month, Walk-and-Talk Meetings, nilo.health & mindfulness courses, "PME Familienservice", employee surveys.

• Team & Collaboration: People culture, communities & networks, co-working spaces, leadership guidelines, canteen.

• Mobility: Public transport allowance, bicycle parking, free car parking, e-charging stations.

This is Us

At Essity, our Beliefs & Behaviours (Care, Collaboration, Courage, and Commitment) is the foundation for our inclusive culture and as such something we are living on an everyday basis. With a purpose of Breaking Barriers to Well-being, diversity, equity & inclusion is established in our core.

We are committed against discrimination on the basis of color, ethnicity, migration history, religion, sex, national origin, sexual orientation, age, citizenship status, marital status, caregiving responsibilities, disability, chronic illness, gender identity, gender expression, genetic information, and other. We explicitly welcome applications from people who are structurally, institutionally, intersectionally discriminated.

#Essity-DE

Enddatum der Bewerbung:

Job Requisition ID:

Essity250998