At a Glance
- Tasks: Guide regulatory strategies for innovative healthcare technologies and manage submissions.
- Company: Join a leading semiconductor company transforming healthcare with cutting-edge solutions.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on innovation and collaboration.
- Why this job: Be part of a team making a real difference in patient care and health technology.
- Qualifications: Master's in Regulatory Affairs and experience with FDA regulations required.
The predicted salary is between 50000 - 65000 £ per year.
About Analog Devices
Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centres.
Summary of the Role/About the Team & Org
ADI’s Digital Healthcare Group is developing novel remote monitoring solutions that improve patient care and quality of life, while keeping costs low. The Digital Healthcare Group is looking for an energetic, Principal Regulatory Affairs Specialist for the development of novel solutions.
Specific Responsibilities / Duties
- Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering FDA regulations.
- Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions.
- Participate in negotiations and interactions with regulatory authorities during the development and review process.
- Support international product registrations as needed.
- Manage multiple projects and prioritise tasks on a day-to-day basis to meet project schedules.
- Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfil responsibilities.
- Review promotional and advertising material.
- Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards.
- Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements.
- Participate in internal and external audits as needed.
- Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements.
- Ensure compliance with design controls in accordance with ISO 13485 standard and 21 CFR 820 regulation.
- Manage Internal Audit program in accordance with ISO 13485 and MDSAP and host all 3rd party audits including FDA.
- Provide training of QMS processes.
- Perform other duties as assigned or required.
Previous Experience/Skills Needed & Education Requirements
- MS Regulatory Affairs.
- Experience with ISO 13485, MDSAP and FDA QSR.
- Should be willing to learn & shouldn’t be afraid of getting their hands dirty!
For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.
Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.
Regulatory Affairs Specialist in Cambridge employer: Analog Devices, Inc.
Analog Devices, Inc. is an exceptional employer that champions innovation and collaboration within the semiconductor industry, particularly in the vibrant city of Cambridge, UK. With a strong commitment to employee growth, ADI offers comprehensive training and development opportunities, fostering a dynamic work culture that values diversity and inclusion. Employees benefit from engaging in meaningful projects that contribute to advancements in healthcare and technology, all while enjoying a supportive environment that prioritises work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist in Cambridge
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Analog Devices, Inc. looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Affairs Specialist in Cambridge
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Analog Devices, Inc.. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Analog Devices, Inc.
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Analog Devices, Inc.’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
