Aktuelle Jobs im Zusammenhang mit Head of Regulatory Affairs Medical Devices - Heidenheim an der Brenz, Baden-Württemberg - PAUL HARTMANN AG
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Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJoin Our Team as a Regulatory Affairs Manager for Post-Market SurveillanceWe are seeking a highly skilled Regulatory Affairs Manager to join our team at PAUL HARTMANN AG. As a key member of our regulatory team, you will be responsible for ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance...
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vor 1 Monat
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Regulatory Affairs Specialist
vor 4 Wochen
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Werkstudent Regulatory Affairs
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Head of Regulatory Affairs Medical Devices
vor 2 Monaten
Job Summary
We are seeking a highly skilled and experienced Regulatory Affairs Leader to join our team at PAUL HARTMANN AG. As the Head of Regulatory Affairs Medical Devices, you will be responsible for ensuring compliance with all regulatory requirements of our medical device portfolio in all relevant markets.
Key Responsibilities
- Develop and implement regulatory strategies to ensure compliance with medical device regulations, such as MDR, MDD, and MPG/MPDG/MPSV.
- Lead the divisional Regulatory Affairs department, comprising a team of six members, and provide guidance on regulatory matters.
- Evaluate and define the proper regulatory strategy approach for each product, ensuring alignment with commercial objectives.
- Manage, coordinate, and contribute to post-market surveillance, labeling, regulatory product documentation, conformity assessments, and clinical, biological, risk management, usability, standards & regulations management.
- Contribute to the writing and reviewing of Regulatory processes, ensuring resources and activities are aligned with commercial objectives.
Requirements
- A University degree in life science, natural science, or an equivalent qualification.
- At least 5 years of relevant professional experience in a Regulatory Affairs role within an international company.
- Qualification as PRRC according to MDR.
- Comprehensive knowledge of regulatory requirements for medical devices, personal protective equipment, and In-vitro diagnostics related to product safety and risk management.
- Proven experience in leading and developing a team.
- Strong project management skills, with a preference for experience in managing international projects.
- Excellent communication and collaboration skills, with experience working effectively with cross-functional stakeholders at all levels, including in a matrix organization.
- Fluent written and spoken English and German.
What We Offer
- Flexible working conditions, such as flexible working hours and mobile working.
- International Mobile Working.
- Attractive ways of combining work and family life, e.g. childcare subsidy.
- Company vehicle incl. private usage.
- 30 days paid leave per year, plus special leave for exceptional life events.
- Company pension plan with attractive employer contribution incl. matching model for deferred compensation.
- Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop.
- Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass).
- Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
- Job Bike Leasing.
- Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform.
