Aktuelle Jobs im Zusammenhang mit Senior Regulatory Affairs Specialist - Böblingen - Philips
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Regulatory Affairs Expert
vor 3 Wochen
Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma Vollzeit**About Wörwag Pharma**We are a medium-sized, internationally active, family-owned pharmaceutical company headquartered in Germany. Our mission is to fight civilization diseases through preventive, accompanying, and healing measures. Our corporate culture is characterized by a colorful and collegial atmosphere among our 1,200 employees worldwide.**Job...
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Regulatory Affairs Expert
vor 3 Wochen
Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma Vollzeit**About Wörwag Pharma**We are a medium-sized, internationally active, family-owned pharmaceutical company headquartered in Germany. Our mission is to fight civilization diseases through preventive, accompanying, and healing measures. Our corporate culture is characterized by a colorful and collegial atmosphere among our 1,200 employees worldwide.**Job...
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Senior Director of Clinical Affairs
vor 2 Wochen
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Senior Director of Clinical Affairs
vor 2 Wochen
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitJob Title: Senior Director of Clinical AffairsPhilips is seeking a highly experienced Senior Director of Clinical Affairs to lead our clinical affairs team and drive strategic business decisions.About the Role:Provide thought leadership on key clinical topics to support strategy development and execution.Build and lead a high-performing clinical affairs team...
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Senior Director of Clinical Affairs
vor 1 Woche
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Senior Director of Clinical Affairs
vor 1 Woche
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitJob Title: Senior Director of Clinical AffairsPhilips is seeking a highly experienced Senior Director of Clinical Affairs to lead our clinical affairs team and drive strategic business growth. As a key member of our leadership team, you will be responsible for delivering clinical knowledge, experience, and expertise across the entire value chain from...
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Senior Director of Clinical Affairs
Vor 3 Tagen
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitJob Title: Senior Director of Clinical AffairsPhilips is seeking a highly experienced Senior Director of Clinical Affairs to lead our clinical strategy and operations. As a key member of our team, you will be responsible for delivering clinical knowledge, experience, and expertise across the entire value chain from ideation to end-of-life.About the...
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Senior Director of Clinical Affairs
Vor 3 Tagen
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitJob Title: Senior Director of Clinical AffairsPhilips is seeking a highly experienced Senior Director of Clinical Affairs to lead our clinical strategy and operations. As a key member of our team, you will be responsible for delivering clinical knowledge, experience, and expertise across the entire value chain from ideation to end-of-life.About the...
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Medical Writer Specialist
Vor 3 Tagen
Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma VollzeitJoin Our Team as a Specialist Medical WriterWe are seeking a highly skilled Specialist Medical Writer to join our team at Wörwag Pharma. As a Specialist Medical Writer, you will be responsible for preparing parts of eCTD dossiers relevant for marketing authorizations in accordance with regulatory and internal specifications for European and global marketing...
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Medical Writer Specialist
Vor 3 Tagen
Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma VollzeitJoin Our Team as a Specialist Medical WriterWe are seeking a highly skilled Specialist Medical Writer to join our team at Wörwag Pharma. As a Specialist Medical Writer, you will be responsible for preparing parts of eCTD dossiers relevant for marketing authorizations in accordance with regulatory and internal specifications for European and global marketing...
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Senior Director of Clinical Affairs
Vor 6 Tagen
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitJob Title: Senior Director of Clinical AffairsAbout the Role:We are seeking a highly experienced Senior Director of Clinical Affairs to join our team at Philips. As a key member of our organization, you will be responsible for delivering clinical knowledge, experience, and expertise across the entire value chain from ideation to end-of-life.Key...
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Senior Director of Clinical Affairs
Vor 6 Tagen
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitJob Title: Senior Director of Clinical AffairsAbout the Role:We are seeking a highly experienced Senior Director of Clinical Affairs to join our team at Philips. As a key member of our organization, you will be responsible for delivering clinical knowledge, experience, and expertise across the entire value chain from ideation to end-of-life.Key...
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Medical Writer Specialist
vor 1 Woche
Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma Vollzeit{"h1": "Join Wörwag Pharma as a Specialist Medical Writer", "p": "At Wörwag Pharma, we are looking for a highly skilled Specialist Medical Writer to join our team in Böblingen, Germany. As a Specialist Medical Writer, you will be responsible for preparing parts of eCTD dossiers, reviewing and evaluating clinical and non-clinical documents, and...
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Medical Writer Specialist
vor 1 Woche
Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma Vollzeit{"h1": "Join Wörwag Pharma as a Specialist Medical Writer", "p": "At Wörwag Pharma, we are looking for a highly skilled Specialist Medical Writer to join our team in Böblingen, Germany. As a Specialist Medical Writer, you will be responsible for preparing parts of eCTD dossiers, reviewing and evaluating clinical and non-clinical documents, and...
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Senior Director of Clinical Affairs
vor 3 Wochen
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitAbout the RoleWe are seeking a highly experienced and skilled Senior Director of Clinical Affairs to join our team at Philips. As a key member of our organization, you will play a critical role in driving our clinical strategy and ensuring that our products and solutions meet the highest standards of quality and safety.Key ResponsibilitiesProvide thought...
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Senior Director of Clinical Affairs
vor 3 Wochen
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitAbout the RoleWe are seeking a highly experienced and skilled Senior Director of Clinical Affairs to join our team at Philips. As a key member of our organization, you will play a critical role in driving our clinical strategy and ensuring that our products and solutions meet the highest standards of quality and safety.Key ResponsibilitiesProvide thought...
-
Senior Director of Clinical Affairs
vor 3 Wochen
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitAbout the RoleWe are seeking a highly experienced and skilled Senior Director of Clinical Affairs to join our team at Philips. As a key member of our organization, you will play a critical role in driving our clinical strategy and ensuring that our products and solutions meet the highest standards of quality and safety.Key ResponsibilitiesProvide thought...
-
Senior Director of Clinical Affairs
vor 3 Wochen
Böblingen, Baden-Württemberg, Deutschland Philips VollzeitAbout the RoleWe are seeking a highly experienced and skilled Senior Director of Clinical Affairs to join our team at Philips. As a key member of our organization, you will play a critical role in driving our clinical strategy and ensuring that our products and solutions meet the highest standards of quality and safety.Key ResponsibilitiesProvide thought...
-
Medical Writer Specialist
vor 2 Wochen
Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma Vollzeit{"h1": "Join Wörwag Pharma as a Specialist Medical Writer", "p": "At Wörwag Pharma, we are looking for a highly skilled Specialist Medical Writer to join our team in Böblingen, Germany. As a Specialist Medical Writer, you will be responsible for preparing parts of eCTD dossiers, reviewing and evaluating clinical and non-clinical documents, and...
-
Medical Writer Specialist
vor 2 Wochen
Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma Vollzeit{"h1": "Join Wörwag Pharma as a Specialist Medical Writer", "p": "At Wörwag Pharma, we are looking for a highly skilled Specialist Medical Writer to join our team in Böblingen, Germany. As a Specialist Medical Writer, you will be responsible for preparing parts of eCTD dossiers, reviewing and evaluating clinical and non-clinical documents, and...
Senior Regulatory Affairs Specialist
vor 4 Monaten
Job Title
Senior Regulatory Affairs Specialist (m/w/d) Medical Device
Job Description
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
You are responsible for
Develop global regulatory strategies to meet business objectives and collaborate across a matrixed organization to ensure global success of products
Participate in cross-functional project teams and provide regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy for new product introduction
Responsible for worldwide product registration submissions/approvals as well as license renewals and updates.
Prepare FDA and Health Canada submissions and European Technical Documentation (EU MDR) for product changes and/or new product introductions.
Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed
Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements.
Analyze and optimize RA processes together with cross functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs in order to improve procedures or integrate new and changing Standards and regulations
You are part of
Philips Medical Systems Böblingen GmbH, an established leader in patient monitoring. We develop and produce patient monitoring systems for a worldwide market. Our products are used in emergency and intensive care, pregnancy and neonatal monitoring, as well as for anesthesia. You are joining a growing and dynamic Regulatory Affairs department with colleagues collaborating globally.
To succeed in this role, you should have the following skills and experience
Degree in mechanical engineering, electrical engineering or applied sciences or related discipline
Prior proven experience of the 510(k) or Q-Sub or De Novo or PMA Submission and approval Process
Several years of experience plus professional experience in medical device regulatory affairs
Strong experience creating other global regulatory submission plans, submission file preparation and receiving submission approval (EU, Canada, etc)
Expertise with interpreting and implementing various medical device standards and global medical devices,
such as electrical safety, EMC testing (e.g., IEC 62304, IEC60601 series etc.)
Experience with systems for quality management, product development and follow-up of procedures is an advantage.
Experience in process improvement, process implementation, facilitation of critical meetings.
Experience in project management is required.
Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP etc.)
Coaching/mentoring skills to develop talents is required.
Fluent in English, other European languages beneficial
In return, we offer you
We believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule, and access to local well-being-focused activities. Philips encourages people with a disability to apply.
Attractive non-tariff-based compensation
Annual salary adjustments and bonus
30 days of annual leave
Purpose: Doing meaningful work with a great team
Hybrid work concept: Up to two days a week "working from home"
Philips Pension Fund: Employer-funded pension plan
Mobility and devices: Leasing bicycles, cars, and also smartphones for private use
Culture: Informal culture, a paid day for voluntary work, various team/cultural activities (on sustainability, diversity, ...), etc.
Philips University: Wide range of professional training courses and for personal development
Philips MyShop: Discount on Philips products
Philips in Balance: Various offers for physical and mental health and sports courses
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion.
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