Regulatory Affairs Specialist
Il y a 6 mois
**Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
**Interviews** (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities
**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
We look forward to meeting you
**Job description**:
**About Us**: We are a leading company dedicated to healthcare, engineering, and pharmaceutical innovations. As we continue to expand our impact on global health, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. Our organization is committed to upholding the highest standards of quality, and we are looking for an individual with expertise in Corrections and Removals (C&R), Corrective and Preventive Action (CAPA), and Process Quality Engineering.
**Responsibilities**:
- Serve as a Corrections and Removals (C&R) Specialist for our IGT Systems, ensuring compliance with relevant regulations.- Lead Corrective and Preventive Action (CAPA) initiatives, driving continuous improvement in product quality and regulatory compliance.- Collaborate with cross-functional teams to implement and maintain robust Quality Management Systems.- Act as a Process Quality Engineer, identifying areas for improvement and implementing effective solutions.- Work closely with international regulatory bodies to facilitate product approvals and compliance.- Provide regulatory guidance to project teams, ensuring regulatory considerations are integrated into product development processes.- Stay current with changes in regulatory requirements and communicate updates to relevant stakeholders.- Contribute to the development and maintenance of regulatory documentation.- Collaborate with Quality Management teams to ensure seamless regulatory compliance.**Qualifications**:
- HBO/Bachelor and/or MSc/WO in Healthcare, Engineering, Science, Biomedical, or Pharma.- Minimum of 5 years of experience in Regulatory Affairs within the healthcare or related industry.- Expertise in Corrections and Removals (C&R), Corrective and Preventive Action (CAPA), and Process Quality Engineering.- In-depth knowledge of regulatory standards like; 21 CFR Parts 803, 806, and 820, EU MDR, ISO 13485, ISO 14971, Canadian Medical Devices Regulation, or Japanese MHLW Ordinance 169.- Proficient in English, both written and spoken.**What we offer**:
Join our dynamic team of talented people and discover a world full of growth and opportunity. Here's what we offer:
- Rapid growth through a personalized career path and salary evaluation. 70% of our senior leaders started in entry-level roles.
- A competitive salary and benefits package
- Hone your skills through our catalogue of our Technology Academy, the Udemy platform, language lessons, webinars and workshops.
- Take control of your training with an annual personal budget and company-paid certifications.
- Enjoy flexible policies, remote work options, and great social benefits like transportation, help with relocation for internationals and collective health insurance.
- Take advantage of our WeCare program, which provides support to employees in critical situations.
- Unleash your full potential, both professionally and personally.
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