Regulatory Affairs Manager Emea/apac

hace 3 semanas


En remoto, España Blu Selection A tiempo completo

Our client is looking for a dynamic and experienced Manager of Regulatory Affairs and Compliance to oversee the Regulatory Affairs functions for the EMEA and APAC regions.

Tasks

Your Responsibilities and Impact as Regulatory Affairs Manager will be:

- Supervising Regulatory Affairs for EMEA and APAC jurisdictions, ensuring adherence to procedures and practices for new product submissions, registrations, change assessments, and more.
- Developing product regulatory strategies and overseeing their execution for timely product launches in EMEA and APAC markets.
- Assessing technical documentation updates and coordinating submissions to regulatory agencies across key markets.
- Managing relationships with Economic Operators and acting as the primary point of contact for Regulatory and Compliance matters.
- Leading the change review process, monitoring global regulatory changes, and ensuring timely compliance updates.
- Participating in Change Control Process (CCP) and Management Review (MR) forums for EMEA and APAC.
- Providing support to subsidiary companies in EMEA and APAC for their interactions with Regulatory Agencies.

**Requirements**:
Skills, experience and interests you will need to succeed in this role:

- University Degree in an applied science or related area, or equivalent experience.
- 8+years of experience in Quality Systems for Medical Devices.
- Minimum of 6 years of regulatory affairs experience, with at least 3 years in a management capacity.
- Significant experience in implantable devices, including familiarity with EU MDR Annex XVI devices.
- Knowledge of product registrations in China.
- Native level of English; proficiency in additional languages (Spanish, French, Portuguese or Korean) is a plus.
- Having knowledge of relevant regulations, including ISO 13485, FDA 21 CFR Part 820, EU MDR, UK MDR, and more.
- Excellent communication skills, both oral and written, with the ability to collaborate across interdisciplinary teams.
- Ability to handle confidential information with discretion.

**Benefits**:
What´s in it for you?
- Competitive salary
- Great career perspectives
- Work in an international environment
- Collaborating with internal and external international stakeholders
- Permanent contract (40 hours contract - from Monday to Friday)

Your future company

Our client is a rapidly growing global team at a renowned global medical technology company. The organization is dedicated to enhancing patient safety and aesthetic outcomes, with a primary focus on the breast aesthetics and reconstruction market. With a robust portfolio of cutting-edge silicone gel-filled breast implants, they are revolutionizing the femtech industry through innovative design, development, manufacturing, and marketing.


  • (Senior) Director

    hace 1 mes


    En remoto, España Qiagen A tiempo completo

    **Overview** At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the...

  • Regional Manager

    hace 1 mes


    En remoto, España Rippling A tiempo completo

    **About Rippling** Rippling gives businesses one place to run HR, IT, and Finance. It brings together all of the workforce systems that are normally scattered across a company, like payroll, expenses, benefits, and computers. For the first time ever, you can manage and automate every part of the employee lifecycle in a single system. Take onboarding, for...


  • En remoto, España Revolut A tiempo completo

    **About Revolut** - People deserve more from their money. More visibility, more control, more freedom. And since 2015, Revolut has been on a mission to deliver just that. With an arsenal of awesome products that span spending, saving, travel, transfers, investing, exchanging and more, our super app has helped 25+ million customers get more from their money....


  • En remoto, España Qiagen A tiempo completo

    **Overview** At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the...


  • En remoto, España Autodesk A tiempo completo

    Job Requisition ID # - 24WD76992 Position Overview We are looking for Construction Technology professionals who are passionate about driving digital transformation throughout the construction industry. Reporting to the Manager of Construction Customer Success Territory, you will build lasting and meaningful relationships throughout a diverse portfolio of...


  • En remoto, España Novus International A tiempo completo

    General Responsibilities: - Own and drive the EMEA Swine marketing plan. Capture key insights, initiatives, key segment pursuits and drive the solutions approach consistent with corporate strategy. - Execute the marketing & strategy plan in collaboration with the commercial organization to meet Novus’ AOP. - Carry on Cross-functional collaboration with...


  • En remoto, España Veritas Technologies A tiempo completo

    About VERITAS Veritas solves what no one else can. With an industry-leading product portfolio, we offer proven, modern, and integrated technology that brings together availability, protection, and insights. Our Veritas Enterprise Data Services Platform addresses current and future data issues end-to-end - keeping mission-critical workloads highly available,...

  • Platform&service Bd

    hace 1 mes


    En remoto, España Quectel Wireless Solutions North America Corp. A tiempo completo

    Main responsible for Export business ,EMEA & APAC local business. - Build, execute and maintain a business plan, which achieves the tactical, strategic, and financial objectives, for the assigned region within the IoT Platforms marketplace. - Maintain accurate data and forecasts within the Salesforce CRM system across different IoT product lines and various...


  • En remoto, España Leonardo.Ai A tiempo completo

    Leonardo AI is an innovative Australian company leading the generative artificial intelligence (AI) sector with over 10M users and 1B images generated on the platform. The platform empowers artists and creators to By providing a variety of tools and pre-trained models, Leonardo AI is dedicated to democratising creativity and reducing the friction between...


  • En remoto, España Research Management Consulting A tiempo completo

    **Responsibilities** Act as point of contact with EU residents, supervisory authorities and internal teams Identify and evaluate the company’s data processing activities Monitor data management procedures and compliance within the company Liaise with other organisations that process data on our behalf **Requirements and skills** Experience in data...


  • En remoto, España Premier Research A tiempo completo

    At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all....

  • Lead Program Manager

    hace 7 días


    En remoto, España Sabre A tiempo completo

    Sabre is a technology company that powers the global travel industry. By leveraging next-generation technology, we create global technology solutions that take on the biggest opportunities and solve the most complex challenges in travel. Positioned at the center of the travel, we shape the future by offering innovative advancements that pave the way for a...


  • En remoto, España IQVIA A tiempo completo

    **PURPOSE**: As a Translation Vendor Manager you will be responsible for selecting a number of linguists as well as building strong relationships with them and the IQVIA Translations Services team. You will be part of an international team of dedicated language experts and Subject Matter Experts (SMEs) delivering high-standard translation services. You...


  • En remoto, España Approach People A tiempo completo

    Our client is a world leader in the manufacture and supply of alloy systems and metals. To expand their business internationally and fuel their exciting growth plans, our client is looking for a Business Development Manager who will be researching and developing new business opportunities for both their existing and new range of products. If you are...

  • Project Manager

    hace 1 mes


    En remoto, España TQS Integration A tiempo completo

    **Role**: Senior Project Manager **Status**:Full Time, Regular **Location**:We are open to remote roles across Spain/EMEA, or in suitable compatible time zones **Key Duties / Responsibilities**: - Define the scope of a portfolio of projects or program in collaboration with senior management. - Create a detailed work plan which identifies and sequences...


  • En remoto, España Dexcom A tiempo completo

    **About Dexcom**: Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of...


  • En remoto, España Autodesk A tiempo completo

    Job Requisition ID # - 24WD76990 Position Overview We are looking for Construction Technology professionals who are passionate about driving digital transformation throughout the construction industry. Reporting to the Manager of Construction Customer Success Territory, you will build lasting and meaningful relationships throughout a diverse portfolio of...


  • En remoto, España Premier Research A tiempo completo

    At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all....


  • En remoto, España Warman O'Brien A tiempo completo

    Within this role, you will be responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with SOPs, GCP and regulatory requirements. You will also engage with clinical sites to develop, build, and maintain strong...


  • En remoto, España ICON A tiempo completo

    ICON has an exciting new opportunity for a Global Project Manager to join a growing and successful team. This is a home-based and permanent role. Key Responsibilities: Responsible for: - Lead the development of realistic study timelines, from design through final study reporting Maintaining accuracy of clinical study timeline information in data control...