Senior Legal Counsel, Regulatory Emea
vor 4 Wochen
**Job Description Summary**: The Senior Counsel, Regulatory Law EMEA, will be a member of the EMEA Law Group and will report to Chief Regional Counsel EMEA and EMEA-based businesses with a strong dotted line to the VP Compliance Officer and Chief Regulatory Counsel.
**We are the makers of possible**
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
**Why Join Us?**
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us
**Position Responsibilities will include, but are not limited to, the following**:
- Provide expert advice and counsel to supported businesses concerning complex regulatory matters with a focus on MDR/IVDR and medical device regulations in the EMEA region.
- Advise on legal issues throughout the medical device life cycle related to recalls, promotion and advertising, clinical studies, medical device reporting, drug adverse event reporting, corrections and removals, product clearance and approvals, inspections, and quality system compliance.
- Maintain knowledge of current medical device and drug regulatory law, pending legislative and regulatory changes, and enforcement actions to maintain the highest level of expertise.
- Provide legal counsel to clients on a variety of regulatory and quality matters, including pre-market approval and post-market surveillance, promotional issues, product development issues and other regulatory matters.
- Provide legal counsel during regulatory agency investigations and/or administrative actions brought against the Company with particular emphasis on regulatory issues.
- Provide legal advice and guidance on global trade matters, including import/export compliance, customs, supply chain, and global trade regulations.
- Review and provide legal guidance on the implementation of the Company’s global trade compliance programs and policies.
- Monitor and analyze legal and regulatory changes in global trade laws and regulations and advise the Company’s business leadership on the legal impact of such changes.
- Provide day to day legal advice and oversight to a variety of constituents including management, customers, and governmental officials on a range of EH&S matters.
- Understand and be able to translate into “plain English” the legal ramifications of varied legal and regulatory risks.
- Ability to contemplate the legal implications of new innovations and collaborate with the business to develop regulatory strategies for new technologies.
- Develop strong relationships throughout all functional areas, departments, and divisions to foster an advisory or collaborative approach to proactive compliance.
- Knowledge of EU REACH, CSRD and CS3D preferred.
- Commercially oriented, understanding the nuances of complicated regulatory issues and able to think creatively to solve problems and mitigate risk while supporting business objectives.
- Keeps up to date on all current and pending environmental, health and safety legislation and regulations.
- Support regulatory due diligence for new business and product acquisitions.
The position is ideal for a detail oriented, knowledgeable, independent, self-starter who is interested in achieving a high degree of success in a collaborative environment.
**Qualifications**:
- Master degree from an accredited law school. Licensed to practice law in an EU memberstate.
- At least 5 years of relevant experience in regulatory and/or trade law.
- Working knowledge of EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) and experience advising clients on U.S. and/or EU medical device regulatory law is required.
- Experience advising clients relating to Quality System regulations, Good Manufacturing Practices (GMPs), EU Drug Safety/Pharmacovigilance, and clinical trials preferred.
- Experience on EU trade regulations is a plus.
- A demonstrated ability to lead through influence and navigate controversial situations and negotiations.
- Excellent analytical, communication, and drafting s
-
Lead Regional Legal Counsel Europe Abb E-mobility
vor 4 Monaten
Heidelberg, Deutschland ABB Vollzeit**Lead Regional Legal Counsel Europe ABB E-mobility**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and...
-
Legal Counsel
vor 5 Monaten
Heidelberg, Deutschland ХайдельбергЦемент VollzeitDie Konzernrechtsabteilung Group Legal & Compliance der Heidelberg Materials AG erbringt die Rechtsberatung für das Management des Heidelberg-Materials-Konzerns, für andere Konzernfunktionen und für das operative Geschäft unserer Tochtergesellschaften in Deutschland. Wir agieren dabei in einem ausgesprochen internationalen Umfeld, stehen im Austausch mit...
-
Legal Counsel
vor 5 Monaten
Heidelberg, Deutschland Heidelberg Materials AG VollzeitDie Konzernrechtsabteilung Group Legal & Compliance der Heidelberg Materials AG erbringt die Rechtsberatung für das Management des Heidelberg-Materials-Konzerns, für andere Konzernfunktionen und für das operative Geschäft unserer Tochtergesellschaften in Deutschland. Wir agieren dabei in einem ausgesprochen internationalen Umfeld, stehen im Austausch mit...
-
(Associate) Legal Counsel
vor 5 Monaten
Heidelberg, Deutschland ХайдельбергЦемент VollzeitDie Konzernrechtsabteilung der Heidelberg Materials AG erbringt die Rechtsberatung für das Management des Heidelberg-Materials-Konzerns, für andere Konzernfunktionen und für das operative Geschäft unserer Tochtergesellschaften in Deutschland. Wir agieren dabei in einem ausgesprochen internationalen Umfeld, stehen im Austausch mit unterschiedlichsten...
-
Senior Regulatory Specialist
vor 7 Monaten
Heidelberg, Deutschland Archer Daniels Midland Company VollzeitHeidelberg Germany Legal, Compliance, Regulatory Affairs, Corporate Security **Senior Regulatory Specialist - Chemical and hazardous substances law (M/F/d)** **Location : Heidelberg/Germany** **Your role**: - Calculation of the classification of hazardous substances according to the GHS/CLP regulation with the use of SAP EHS - Maintenance and updating...
-
(Associate) Legal Counsel
vor 5 Monaten
Heidelberg, Deutschland Heidelberg Materials AG VollzeitDie Konzernrechtsabteilung der Heidelberg Materials AG erbringt die Rechtsberatung für das Management des Heidelberg-Materials-Konzerns, für andere Konzernfunktionen und für das operative Geschäft unserer Tochtergesellschaften in Deutschland. Wir agieren dabei in einem ausgesprochen internationalen Umfeld, stehen im Austausch mit unterschiedlichsten...
-
Regulatory Specialist
vor 7 Monaten
Heidelberg, Deutschland Archer Daniels Midland Company VollzeitHeidelberg Germany Legal, Compliance, Regulatory Affairs, Corporate Security **Regulatory Specialist (M/F/d)** **Location : Heidelberg/Germany** **Your role**: - Evaluation of raw materials and products for the food and beverage industry in consideration of European and international food law regulations - Data maintenance in central SAP system -...
-
Regulatory Specialist
vor 7 Monaten
Heidelberg, Deutschland Archer Daniels Midland Company VollzeitHeidelberg Germany Legal, Compliance, Regulatory Affairs, Corporate Security **Regulatory Specialist - fixed-term (M/F/d)** **Location : Heidelberg/Germany** **Your role**: - Evaluation of raw materials and products for the food and beverage industry in consideration of European and international food law regulations - Data maintenance in central SAP...
-
Regulatory Specialist
vor 5 Monaten
Heidelberg, Deutschland Archer Daniels Midland Company VollzeitHeidelberg Germany Legal, Compliance, Regulatory Affairs, Corporate Security **Regulatory Specialist - Schwerpunkt Halal (m/w/d)** **Im Bereich Regulatory & Scientific Affairs am Standort Heidelberg** ADM setzt die Kraft der Natur frei, um die Lebensqualität zu bereichern. Wir sind ein führendes globales Unternehmen für die Ernährung von Mensch und...
-
Regulatory Specialist
vor 5 Monaten
Heidelberg, Deutschland Archer Daniels Midland Company VollzeitHeidelberg Germany Legal, Compliance, Regulatory Affairs, Corporate Security **Regulatory Specialist - vorerst befristet (m/w/d)** **Im Bereich Regulatory & Scientific Affairs am Standort Heidelberg** Startzeitpunkt: ab sofort Arbeitszeitmodell: Gleitzeit Vollzeit **Deine Rolle** - Du bewertest Rohstoffen und Produkten für die Lebensmittel - und...
-
Business Administrator: Regulatory Affairs
vor 5 Monaten
Heidelberg, Deutschland living brain GmbH Vollzeitliving brain is an award-winning med-tech start-up that brings neurotherapy to the next level. We create personalized, science-based and fun therapy for people with neurological diseases. To get there we combine virtual reality, the latest research and gamification. We believe that every patient deserves the perfectly adapted and functional rehabilitation...
-
Junior Regulatory Specialist
vor 5 Monaten
Heidelberg, Deutschland Archer Daniels Midland Company VollzeitHeidelberg Germany Legal, Compliance, Regulatory Affairs, Corporate Security Im Bereich Regulatory & Scientific Affairs am Standort Heidelberg **Deine Rolle** - Du bewertest Rohstoffe und Produkte für die Lebensmittel - und Getränkeindustrie unter Berücksichtigung europäischer und internationaler lebensmittelrechtlicher Vorschriften - Du pflegst die...
-
Junior Regulatory Specialist
vor 5 Monaten
Heidelberg, Deutschland Archer Daniels Midland Company VollzeitHeidelberg Germany Legal, Compliance, Regulatory Affairs, Corporate Security Im Bereich Regulatory & Scientific Affairs am Standort Heidelberg Startzeitpunkt: ab sofort Arbeitszeitmodell: Gleitzeit Vollzeit Unbefristet **Deine Rolle** - Du bewertest Rohstoffe und Produkte für die Lebensmittel - und Getränkeindustrie unter Berücksichtigung...
-
Senior Legal Officer
vor 5 Monaten
Heidelberg, Deutschland European Molecular Biology Laboratory VollzeitAdministration - EMBL Heidelberg We are Europe’s research laboratory for the life sciences - an intergovernmental organisation performing scientific research in disciplines including molecular biology, physics, chemistry and computer science. We are an international, innovative and interdisciplinary laboratory with more than 1900 employees from many...
-
Regulatory Affairs Specialist
vor 4 Wochen
Heidelberg, Baden-Württemberg, Deutschland Biomatch GmbH VollzeitJob DescriptionBiomatch GmbH, a renowned life science recruitment agency, is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical devices in China.Key ResponsibilitiesPrepare and submit applications and necessary...
-
Regulatory Affairs Specialist
vor 4 Wochen
Heidelberg, Baden-Württemberg, Deutschland Biomatch GmbH VollzeitJob DescriptionBiomatch GmbH, a renowned life science recruitment agency, is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical devices in China.Key ResponsibilitiesPrepare and submit applications and necessary...
-
Legal Counsel
vor 5 Monaten
Heidelberg, Deutschland X-TENTION Informationstechnologie Vollzeit**Bist du bereit mit x-tention die Healthcare IT zu revolutionieren und die Digitalisierung des Gesundheitswesens auf ein neues Level zu heben?**: **Deine Rolle bei x-tention**: - Erstellung, Aktualisierung und Harmonisierung der Allgemeinen Geschäftsbedingungen innerhalb der Unternehmensgruppe - Erstellung und Aktualisierung bzw. Pflege von...
-
Regulatory Affairs Specialist
vor 3 Wochen
Heidelberg, Baden-Württemberg, Deutschland Biomatch GmbH VollzeitAufgabenBearbeitung von Anträgen und Erstellung notwendiger Dokumente sowie Pflege von länderspezifischen Dossiers für die Einreichung bei der chinesischen Behörde NMPA.Aktive Statusverfolgung der Zulassungen der Produkte sowie Einleitung von Maßnahmen zur Erneuerung der Zulassungen bei der NMPA.Erstellung der technischen Dokumentation gemäß den...
-
Legal Counsel Corporate Law
Vor 6 Tagen
Heidelberg, Deutschland Heidelberg Materials AG VollzeitHeidelberg Materials ist einer der weltweit größten integrierten Hersteller von Baustoffen und -lösungen mit führenden Marktpositionen bei Zement, Zuschlagstoffen und Transportbeton. Wir sind mit mehr als 51.000 Beschäftigten an fast 3.000 Standorten in über 50 Ländern vertreten.Im Mittelpunkt unseres Handelns steht die Verantwortung für die Umwelt....
-
Workingstudent Legal
vor 5 Monaten
Heidelberg, Deutschland Reckitt VollzeitHeimat der weltweit beliebtesten und vertrauenswürdigsten Hygiene-, Gesundheits - und Ernährungsmarken. Unser Ziel definiert, warum wir existieren: zu schützen, zu heilen und zu ernähren im unermüdlichen Streben nach einer saubereren, gesünderen Welt. Wir sind ein globales Team, das dieses Ziel vereint. Begleite uns in unserem Kampf, den Zugang zu...
