Această ofertă de loc de muncă nu este disponibilă în țara dvs.

Post Market Surveillance Senior Specialist

Stryker Romania SrlBucharest, Romania

În urmă cu 17 zile

Descrierea postului

Work Flexibility : Hybrid

We are looking for a Post Market Surveillance Senior Specialist to join our PMS EMEA team in Bucharest.

What you will do :

ExecutePMSactivitiesinlinewithdefinedproceduresandprocesses.

Implement post market strategy and processes for handling recalls and communicationtostakeholders(e.g.HCP,patient,distributor,andhealthauthorities)

Reportproductsafetyissuestoregulatoryauthoritiesasrequired,tocomplywith local, regional and global regulations

Assessregulatoryintelligencetoassistinthedevelopmentoflocal,regional regulatory strategies

Collectlocal,national,internationalPostMarketSurveillancerequirementsand options for regulatory submission (adverse events) and compliance activities

Identifietheneedfornewpostmarketprocedures,SOPsandparticipatesin development and implementation

Supportthedevelopmentanddeploymentofnewsystemsandprocedureslocally

SupportcontinuousimprovementactivitiesacrossPMSprocessesattheregional level

Supportintegrationofnewacquisitions&PMSprocessesalignment

Liaise withthelocalbusinessinmanufacturingandDesignDivisionstoensure adequate support for the local RAQA and commercial organizations

ProvidesupporttoEMEA / CountryRAQAteamsandincludedactivitiessitting under the franchise lead role when requested

Prepareregularreportsasrequested : weekly / monthlyreports,supportquality management meetings and audits preparation and readiness

Identifytrainingneeds, develop training materials anddelivertrainingatanyorganizationallevel

AssistotherdepartmentsinthedevelopmentofSOPstoensurepostmarket compliance

What you need :

BS in Engineering, Science, or related degree; or MS in Regulatory Science

Minimum 2 years’ experience

Experience in a highly regulated industry (Medical or Pharma)

Knowledge ofMedicalDeviceDirective (EU / FDA) and Regulations

Fluency in English

Highattentiontodetailandprocessconsciousness

Good communication and analytical skills to engagewithregulatorsandotherkeystakeholdersonroutineand complex matters

Travel Percentage : 10%

Creați o alertă de locuri de muncă pentru această căutare

Senior Specialist • Bucharest, Romania

Locuri de muncă asemănătoare

Senior Infrastructure Specialist

TemenosBucharest, RO

We are looking for a highly skilled and user-centric Senior Modern Workplace Engineer to join our team responsible for the design, deployment, and continuous improvement of our digital employee exp...Afișați mai multeUltima actualizare: acum 18 zile

Senior Risk Specialist

SAPBucharest, RO

Employment Type : Regular Full Time.Hiring Manager : Viktoria Merz .As one of the integral elements of SAP's corporate governance & compliance framework, Global Risk & Assurance Services (GR&AS) is m...Afișați mai multeUltima actualizare: acum 30+ zile

Senior Payroll Specialist

StefaniniBucharest, Romania

Responsible for the monthly payroll calculation, ensuring compliance with local labor / fiscal law and maintain the relationship with the external Payroll provider. .Responsible to collect / prepare all...Afișați mai multeUltima actualizare: acum 30+ zile

Senior QA Specialist

Teva PharmaceuticalsBucharest, Romania

Sindan, part of Teva Group, is a pharmaceutical company dedicated to oncology treatments, founded in 1991, within the structure of the Research Department of the Bucharest Oncology Institute.In 200...Afișați mai multeUltima actualizare: acum 30+ zile

Quality Manager - Escalation and Regulatory surveillance

Zentiva Group, a.s.Bucharest, Romania

We are a Corporate quality team.Zentiva product supply and commercial operation to ensure appropriate escalation, notification, categorization, mitigation, and health authority reporting, as well a...Afișați mai multeUltima actualizare: acum 18 zile

Senior Sourcing Specialist

HoneywellBucharest, BUCURESTI, Romania

As a Senior Sourcing Specialist at Honeywell, you will be responsible for Fleet category strategy, execution, and results to optimize total cost of ownership across all Strategic Business Groups (S...Afișați mai multeUltima actualizare: acum 30+ zile

Supplier Security Senior Specialist

VodafoneBucuresti, Romania

The role holder will be responsible for : .Developing frameworks, processes and tools to manage supplier security risks.Building and maintaining relationships with internal stakeholders such as Legal...Afișați mai multeUltima actualizare: acum 17 zile

Market Research Analyst

office people Romania S.R.L.Bucharest, Rumänien

În calitate de furnizor de servicii de personal cu experiență, deservim cu succes angajații și clienții noștri în 130 de locații din 10 țări. Previous experience of minimum 2 years in Marketing role...Afișați mai multeUltima actualizare: acum 30+ zile

Senior Marketing Campaign Specialist

VerifoneBucharest

For more than 40 years Verifone has established a remarkable record of leadership in the electronic payment technology industry. Verifone has one of the leading electronic payment solutions brands a...Afișați mai multeUltima actualizare: acum 30+ zile

Senior Tax Specialist

METRO LOGISTICSBucurești, București, RO

HoReCa), and independent traders.In 2025, we were awarded the Top Employer Romania and Europe certification for the fifth consecutive year. This certification places us among the top employers local...Afișați mai multeUltima actualizare: acum 17 zile

Supply Chain Management Sales Specialist - Turkey market (Turkish speaker)

OracleBUCHAREST, Romania

Are you coming from a period of success? Are you interested in developing your sales career in an exciting, fast-paced culture while also feeling part of a collaborative, supportive community? This...Afișați mai multeUltima actualizare: acum 18 zile

Ofertă nouă!

Senior PV Agreements Specialist

IQVIABucuresti, Romania

Senior PV Agreements Specialist.Work closely with project teams to determine appropriate terms and conditions of safety agreements. Develop and prepare safety agreements.Primary customer interface o...Afișați mai multeUltima actualizare: acum 19 ore

Market Indirect Procurement Business Office Specialist

C & ABucharest, RO

We build on traditions as long as they don't stop us from growing.Therefore, we continuously reflect our actions and strive for improvement. This is the only way we can live up to our own standards ...Afișați mai multeUltima actualizare: acum 15 zile

Senior Rewards Specialist

Coca-Cola Hellenic Bottling CompanyBucuresti, Romania

Romania (Bucuresti) Romania (Bucuresti) Human Resources Hybrid Experienced Professionals.Team : People & Culture – Rewards Team. You'll grow with us - on a grand scale, with impact beyond your imagin...Afișați mai multeUltima actualizare: acum 23 ore

Ofertă nouă!

Senior Payroll Specialist

BlackLineBucharest, Romania

It's fun to work in a company where people truly believe in what they're doing!.At BlackLine, we're committed to bringing passion and customer focus to the business of enterprise applications.Since...Afișați mai multeUltima actualizare: acum 2 ore

Ofertă promovată

Surveillance Operator (Bulgarian)

David Kennedy RecruitmentBucharest, Bucharest, Romania

David Kennedy Recruitment is working with a software development and services company delivering end-to-end digital solutions who are looking to recruit a Surveillance Operator with Bulgarian for t...Afișați mai multeUltima actualizare: acum 14 zile

Bulgarian Speaker Surveillance Operator

The lemon ConsultingBucharest, Romania

Quick Apply

Position : Surveillance Operator with Bulgarian.Operate security devices, systems and monitor devices;.Develop and maintain a thorough knowledge of and proficiency in the operation of video monitor ...Afișați mai multeUltima actualizare: acum 21 zile

Senior Market Data Sourcing Manager, Global Procurement

Deutsche BankBucharest

DB Global Technology is Deutsche Bank’s technology centre in Central and Eastern Europe.Since its set-up in 2013, Bucharest Technology Centre (BEX) has constantly proven its capacity to deliver glo...Afișați mai multeUltima actualizare: acum 14 zile