Regulatory Compliance specialist or Manager

hace 2 meses

España Merlin Digital Partner A tiempo completo

We are Merlin Digital Partner, a leading IT and Digital headhunting company with over a decade of experience. We've successfully collaborated with industry heavyweights such as Wallapop, Glovo, Banc Sabadell, and Factorial.
Our emphasis lies in people-centric approaches and optimizing selection processes. Our mission is to revolutionize companies by seamlessly integrating top-tier talent. We are currently looking for a Specialist Regulatory Compliance (PRRC).
The Mission:
The Person Responsible for Regulatory Compliance (PRRC) ensures that the company's medical device products are in full compliance with the European Union's Medical Device Regulation (MDR) 2017/745 and the requirements of ISO 13485. The PRRC is critical in maintaining the company’s commitment to regulatory compliance and product safety.
The Role:

Oversee the regulatory compliance of all medical devices, ensuring conformity with MDR and ISO 13485.
Liaise with Notified Bodies and Competent Authorities for regulatory matters.
Ensure the technical documentation and EU Declarations of Conformity are up to date and compliant.
Supervise post-market surveillance and vigilance activities, ensuring timely reporting of incidents.
Monitor compliance with the requirements concerning the qualification and classification of medical devices.
Conduct internal audits to verify compliance with regulatory requirements.
Participate in strategic planning and provide regulatory guidance.
Ensure all staff are informed of regulatory obligations and changes in regulations.
Maintain an in-depth understanding of global medical device regulations and standards.
Ensure that the distribution of medical devices within EU member states complies with the regulatory requirements, including oversight of post-market surveillance, vigilance, and maintaining traceability throughout the supply chain.

Key Activities:

Keep abreast of regulatory updates and interpret changes to ensure company-wide compliance.
Collaborate with D&D, Quality Assurance, and other departments to ensure regulatory considerations are integrated into the product lifecycle.
Manage the preparation and submission of regulatory filings and registrations.
Facilitate training programs on regulatory requirements for employees.
Act as the point of contact for regulatory authorities and Notified Bodies.

What we expect from you:

Bachelor’s or Master’s degree in life sciences, engineering, legal, or another relevant field.
At least 2 years of experience in regulatory affairs within the medical device industry.
Detailed knowledge of MDR 2017/745, ISO 13485, and related regulatory frameworks.
Experience interacting with regulatory authorities and Notified Bodies is preferred.
Previous experience in a compliance or regulatory leadership position is advantageous.
Strong analytical and strategic thinking skills.
Excellent communication skills with the ability to articulate regulatory requirements.
Thorough and meticulous with documentation.
Leadership skills with the ability to influence and drive organizational compliance.
Proactive and capable of working independently.
Good command of the English language.

Benefits:

Opportunities for professional growth and career advancement.
A dynamic, innovative work environment where creativity and new ideas are encouraged.
Flexible working environment.

Are you ready to be part of the challenge? Contact us
Please note that this is a Hybrid position (Full time: 40 hours/week)(On-site 3 days a week in San Sebastian) + Occasional travel may be required for meetings with regulatory bodies or industry events.

#J-18808-Ljbffr

  • Compliance Manager EU Regulatory

    hace 2 semanas

    España JA Solar A tiempo completo

    Compliance Manager EU Regulatory (m/f/d)Your missionManage overall strategic and tactical organization of contractual and regulatory compliance requirements for PV.Monitor the current policies and systems in place and ensure compliance with legal and regulatory laws.Learn, unlearn, and relearn the dynamically changing ecosystem of compliance and regulatory...

  • Regulatory Compliance Manager

    hace 1 mes

    España buscojobs España A tiempo completo

    Ebury is a hyper-growth FinTech firm, named in 2021 as one of the top 15 European Fintechs to work for by AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration.Regulatory Compliance Manager - EEAMadrid Office - Hybrid: 4 days in the office, 1 day working from...

  • Compliance Specialist

    hace 2 meses

    España DeNexus Inc. A tiempo completo

    Location: Madrid (other locations in Spanish territory can be evaluated) | Full-timePosition Summary/ObjectiveDeNexus is solving actionable cyber-risk management with our DeRISK Software as a Service (SaaS) offering to enhance the decision making of industrial operation risk owners.We are seeking a Compliance Specialist to ensure our products, services...

  • Regulatory Compliance Manager

    hace 1 mes

    España buscojobs España A tiempo completo

    Ebury is a hyper-growth FinTech firm, named in 2021 as one of the top 15 European Fintechs to work for by AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration.Regulatory Compliance Manager - UK & EU Focussed (specialising in MiFID and FX Derivative products)Ebury Leon /...

  • Regulatory Affair Specialist

    hace 3 meses

    España Itex A tiempo completo

    About the Company: Our client is a global leader in producing high-tech medical and aesthetic devices, known for their use of valuable materials and sophisticated design. With offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, this international company is at the forefront of innovation in its field. Job Overview: As...

  • Regulatory Affairs Specialist

    hace 2 meses

    España Arxada A tiempo completo

    Arxada is a global leader in specialty chemicals, committed to solving the world's toughest preservation challenges through innovative science. With a legacy of over a century, we strive to develop sustainable solutions that enhance the health and wellbeing of people, extend the life of vital infrastructure, and reduce ecological footprints. Sustainable...

  • Compliance Manager

    hace 2 semanas

    España Reconocida empresa A tiempo completo

    We are seeking a detail-oriented and experienced Compliance Manager to oversee the company's regulatory and compliance functions. In this role, based in either Marbella or Malta, you will ensure that the organization adheres to all legal requirements, manages relationships with regulatory bodies, and maintains the highest standards of compliance. You will...

  • Senior Regulatory Affairs Specialist

    hace 2 meses

    España Grifols A tiempo completo

    Senior Regulatory Affairs Specialist Barcelona Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in...

  • Regulatory Affairs Manager

    hace 5 días

    España ORBIK Cybersecurity A tiempo completo

    Hardware and software products are increasingly subject to successful cyberattacks, leading to an estimated global annual cost of cybercrime of €5.5 trillion by 2021. Such products suffer from two major problems: a low level of cybersecurity, reflected by widespread vulnerabilities and inconsistent provision of security updates, and an insufficient...

  • VP Regulatory Tax Compliance

    hace 2 meses

    España Santander A tiempo completo

    VP Regulatory Tax ComplianceCountry: Spain SCIB Compliance Europe is looking for a VP Regulatory Tax Compliance, based in the EU. Santander Corporate & Investment Banking (SCIB) is Santander's global division that supports some of the world's most complex and sophisticated corporate and institutional clients, offering customized services and value-added...

  • Compliance Governance Specialist

    hace 2 meses

    España Payoneer A tiempo completo

    Build Your Career | Love your Work | Make a Difference Payoneer's mission is to empower businesses to go beyond - beyond borders, limits and expectations. In today's digital world, Payoneer enables businesses of all sizes from anywhere in the world to access new economic opportunities by enabling them to transact globally as easily as they do...

  • Compliance Governance Specialist

    hace 2 meses

    España Payoneer Inc. A tiempo completo

    Build Your Career | Love your Work | Make a Difference Payoneer’s mission is to empower businesses to go beyond – beyond borders, limits and expectations. In today’s digital world, Payoneer enables businesses of all sizes from anywhere in the world to access new economic opportunities by enabling them to transact globally as easily as they do...

  • Compliance Governance Specialist

    hace 2 meses

    España Payoneer A tiempo completo

    Build Your Career | Love your Work | Make a DifferencePayoneer’s mission is to empower businesses to go beyond – beyond borders, limits and expectations. In today’s digital world, Payoneer enables businesses of all sizes from anywhere in the world to access new economic opportunities by enabling them to transact globally as easily as they do...

  • Regulatory Affairs Specialist- EBD

    hace 2 meses

    España The Zonal Group A tiempo completo

    Job Details: Regulatory Affairs Specialist- EBDFull details of the job. Vacancy Name Vacancy Name Regulatory Affairs Specialist- EBD Vacancy No Vacancy No VN309 Employment Type Employment Type Full-Time Location About the JobSinclair is looking for a Regulatory Affairs Specialist to manage the global product...

  • Compliance Manager

    hace 1 mes

    España Papaya Global A tiempo completo

    DescriptionPapaya Global is a rapidly growing, award-winning B2B tech unicorn with a mission to revolutionize the payroll and payments industry. With over $400M raised from top-tier investors, our innovative technology provides a comprehensive solution for managing global workforces, from hiring and onboarding to managing and paying employees in over 160...

  • Compliance Specialist

    hace 2 meses

    España Jobsandlaw A tiempo completo

    Texto de la oferta publicada por CuatrecasasEn Cuatrecasas buscamos incorporar en nuestra oficina de Barcelona un/a Compliance Audit Specialist con al menos 2 años de experiencia que examine el apropiado diseño de los controles y que supervise su cumplimiento y eficacia en materia de compliance. Se integrará de forma activa en el Área de Compliance y...

  • Senior Compliance Manager

    hace 2 meses

    España Dojo 2022 A tiempo completo

    Diversity, equity, and inclusion at DojoFrom local bakeries to well-known eateries, Dojo payments serve over 140,000 places across the UK. And something that’s fundamental to creating relevant, innovative products at Dojo is to build teams to reflect the diversity of the businesses we serve. Our drive to improve diversity, equity, and inclusion is closely...

  • Regulatory Compliance

    hace 2 meses

    España SeQura A tiempo completo

    About seQura seQura provides innovative, flexible and easy-to-use payment technologies that help merchants acquire, convert and retain more customers. We make a difference in sales performance by tailoring our solutions to different sectors, to address their unique pain points and deliver superior results in Retail, Education (EduQa), Optics (OptiQa),...

  • Senior Compliance Manager

    hace 3 semanas

    España Scope Group A tiempo completo

    We are looking for a Senior Compliance Manager who thrives when working on a variety of subject matters. You should be able to operate independently and manage the development and implementation of the compliance framework for Scope’s credit rating agencies built on excellence and financial industry best practices. You will work very closely with and...

  • Regulatory Affairs Specialist

    hace 5 días

    España Grifols A tiempo completo

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...