528099 Senior Regulatory Affairs Specialist (m/w/d) Medical Device (Regulatory-Affairs-Manager/in)

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.

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.

Regulatory Affairs Manager LCM (m/w/d)
Wörwag Pharma GmbH & Co. KG • Böblingen

Böblingen

ab sofort

Wörwag Pharma – ein mittelständisches, international tätiges Pharmaunternehmen in Familienbesitz mit Hauptsitz in Böblingen bei Stuttgart, das sehr früh die Bedeutung von Biofaktoren erkannt und wissenschaftlich belegt hat. Seit über 50 Jahren sagen wir den Zivilisationskrankheiten unserer Zeit den Kampf an – vorbeugend, begleitend, heilend. Bei uns steht der Mensch im Mittelpunkt: Unser Slogan „Getting closer helping better“ ist dabei nicht nur ein Versprechen gegenüber Ärzten, Apothekern und Patienten. Er ist Ausdruck unserer bunten Unternehmenskultur und unseres kollegialen Miteinanders der inzwischen 1200 MitarbeiterInnen weltweit.

Werden Sie Teil unseres Teams in unserem Headquarter in Böblingen (bei Stuttgart), denn wir suchen Sie zum nächstmöglichen Zeitpunkt als

Regulatory Affairs Manager LCM (m/w/d) Diese Aufgaben erwarten Sie

* Eigenverantwortliche Planung, Vorbereitung und Durchführung von Zulassungsaktivitäten für die die erteilten Zulassungen weltweit innerhalb des vorgegebenen Zeitrahmens. Dies beinhaltet u.a.:

* Definition der regulatorischen und pharmazeutischen Anforderungen an die Einreichungen in enger Zusammenarbeit mit den internationalen Ansprechpartnern
* Erstellung, Pflege und Zusammenstellung der behördlichen Unterlagen für Verlängerungen, Änderungsanzeigen und ggf. Neueinreichungen
* Elektronische Einreichungen (Bsp. CESP-Portal)
* Koordination und fristgerechte Beantwortung von Anfragen der Behörden
* Pflege und Aktualisierung der regulatorischen Daten und Datenbanken gemäß den gesetzlichen Anforderungen und internen Standards
* Enge Zusammenarbeit und Kommunikation mit anderen Abteilungen, Beratern, Produktionsstandorten und Länderbüros, einschließlich der Entwicklung einer Einreichungsstrategie.
* Überwachung, Interpretation und Umsetzung regulatorischer Entwicklungen und Kommunikation relevanter Änderungen an interne Stakeholder
* Aktive Mitarbeit bei wichtigen Abteilungszielen wie z.B. Compliance-Aktivitäten, Verbesserung der interdisziplinären Zusammenarbeit, Optimierung interner Prozesse & Standards

Das bringen Sie mit
* Abgeschlossenes Studium der Pharmazie, (Veterinär-) Medizin oder einer vergleichbaren Naturwissenschaft; Master of Drug Regulatory Affairs von Vorteil
* Mindestens 3 Jahre Berufserfahrung in Regulatory Affairs in der pharmazeutischen Industrie
* Umfangreiche Kenntnisse der technischen & regulatorischen Anforderungen von Arzneimitteln sowie Erfahrung mit Registrierungen & Lifecycle Management Aktivitäten; weitere Kenntnisse im Bereich Nahrungsergänzungsmittel wünschenswert und von Vorteil
* Fähigkeit Vorgehensweisen und Antworten mit Zulassungsbehörden so zu verhandeln, dass diese sowohl für die Behörde als auch die Firma akzeptabel sind, untermauert durch nachweisliche Erfolge hinsichtlich der Erreichung von Genehmigungen für Registrierungen und Änderungsanzeigen
* Erfahrung in der Anwendung und Pflege von Regulatory Information Management Systemen & Datenbanken
* Präzise, ytische, selbstständige, integrative und verantwortungsbewusste Arbeitsweise sowie werteorientiertes & unternehmerisches Denken und Handeln
* Sehr gute Organisations- und Projektmanagementfähigkeiten, Teamfähigkeit
* Nachweislich exzellente Organisations- und Projektmanagementfähigkeiten, Teamfähigkeit und die Eigenschaft, Aufgaben trotz enger Zeitschienen in detailorientierter, hohen Standards entsprechender Arbeitsweise abzuschließen
* Sehr gute Englischkenntnisse (schriftlich und mündlich; Deutsch- und weitere Sprachkenntnisse von Vorteil)
* Effektive Kommunikationsfähigkeiten, um auch komplexe technische Sachverhalte unterschiedlichen internen Stakeholdern verständlich zu erläutern und Fachthemen sicher zu präsentieren

Das bieten wir Ihnen
* Ein dynamisches, internationales Umfeld mit der Möglichkeit, schnell und umfangreich Verantwortung zu übernehmen, Erfahrungen und Kenntnisse einzubringen und Ideen umzusetzen
* Abwechslungsreiche Herausforderungen sowie spannende Projekte mit starkem Teamspirit
* Eine markt- und leistungsgerechte Vergütung sowie weitere Zusatzleistungen, die Sie nach Ihren Bedürfnissen flexibel nutzen können, wie z.B.

* Zuschuss zur Direktversicherung
* Vergütungsoptionen zur individuellen Nutzung als freie Tage, Altersvorsorge oder Auszahlung
* Bonago Gutscheine zu besonderen Anlässen
* unterstützende Angebote für Ihr allgemeines Wohlbefinden oder zur Vereinbarkeit von Familie und Beruf
* Gesundheitsfördernde Maßnahmen wie z.B. vergünstigte Konditionen auf freiverkäufliche (OTC) Apothekenartikel oder interne Gesundheitstage
* Flexible Vertrauensarbeitszeiten sowie die Möglichkeit bis zu 75% Ihrer Arbeitszeit mobil zu arbeiten
* Zentraler Firmensitz mit guter Anbindung des Nahverkehrs sowie Mobilitätszuschüsse
* Vielfältige Angebote zur persönlichen und fachlichen Weiterbildung
* Regelmäßige Mitarbeiter-Events



Wir freuen uns auf Sie!

Unsere Benefits

* We are Family Good Karma statt Big Pharma. Auch wenn wir uns in den letzten Jahrzehnten zu einem internationalen Pharmaunternehmen entwickelt haben – in uns steckt noch viel von der Stuttgarter Stadtapotheke, mit der alles begann. Vor allem der Wunsch, näher am Menschen zu sein, um besser zuhören, genauer hinsehen und wirklich helfen zu können. Unser Slogan „Getting closer helping better“ ist daher nicht nur ein Versprechen gegenüber Ärzten, Apothekern und Patienten. Er ist Ausdruck unserer Identität und unseres kollegialen Miteinanders. Wir sind ehrlich, offen und helfen uns gerne gegenseitig. Es ist genau diese familiäre und fürsorgliche Teamkultur, die unsere MitarbeiterInnen leben und schätzen. Und zwar an allen unseren Standorten weltweit.
* Viel Spielraum Wir Lassen Sie Wirken! Damit unsere Medikamente wirken, müssen es zuerst unsere MitarbeiterInnen tun. Es ist Teil unserer DNA, ausreichend Spielraum dafür zu

ob 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

Responsible for regulatory planning for new product introductions and product changes, and ensuring maintenance of global regulatory compliance

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

Continuously analyze US, EU, and international regulatory requirements and initiate relevant design changes

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

Provide Regulatory support for Audit, IIA and CAPA

You are a 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’ll need a customer-first attitude and the following

University degree in engineering or scientific discipline

5 years´ plus professional experience in regulatory affairs

Strong experience creating global regulatory submission plans, submission file preparation and receiving submission approval (EU, USA, Canada, etc)

Experience creating and maintaining Technical Documentation as well as responding to reviews made by Notified Bodies or Competent Authorities

In depth experience with evaluation of design, manufacturing, supplier changes with regard to worldwide regulatory requirements

Working knowledge of regulatory standards (e.g. IEC 60601 series, IEC 62304, IEC 62366, ISO 14971)

Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization

Solution and detail-oriented; well organised and self-motivated

Team spirit and good communication skills

Excellent written and oral communication skills in English, German is also preferred  

 

In return, we offer you  

Working in the medical industry brings much fulfilment, as well as unique challenges. You will work in an international agile team with great opportunities for you to explore. You will be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.

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

How we work at Philips  

Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.  

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.  

Our hybrid working model is defined in 3 ways:  

We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.  

We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.  

We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.  

Why should you join Philips?  

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to skin color, religion, age, sex, sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability.