Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living!
We believe that through innovation, development and supporting our customers and patients we can help others achieve a Life Unlimited. Long before any of this is possible, we have to go through many steps that will validate and verify our products.
Regulatory Affairs plays a vital part in the process! Ensuring our products are and remain compliant to the needs of the market, and needs of patients. Our products are in 100 countries globally, and supporting this takes a huge effort.
Supporting this work, were looking for a Regulatory Affairs Specialist, where youll play an important role in preparing and supporting both US and international regulatory submissions and strategies for our growing portfolio. This role will be focused on our Sports Medicine franchise based in the US, that serves our patients and customers to live Life Unlimited.
This position offers the opportunity for you to develop relationships and true partnerships at S+N and with FDA reviewers. You will own the submission, and the questions from the FDA. To achieve this, will require partnering with others in S+N to ensure that accurate evidence and responses are collated and submitted to the regulatory bodies in a timely manner.
This is ideal for an eager regulatory affairs professional who has US Regulatory Submissions experience, who will implement regulatory activities to support currently marketed devices and new product development.
Join us and play a pivotal role in bringing cutting-edge medical devices to markets worldwide!
What will you be doing?
You will be instrumental in ensuring that our products meet all regulatory requirements for global markets. You will develop and implement regulatory strategies, ensuring timely product launches and compliance with all relevant regulations.
- Preparing global regulatory submissions, including 510(k), PMA, MDR Technical Files, and Annual Reports, covering new and modified devices.
- Working closely with our project teams to develop regulatory strategies, testing requirements, and documentation to ensure timely and approved regulatory submissions.
- Keep up-to-date with current and upcoming regulations, standards, and requirements for facility registration, device listing, import/export, and UDI.
- Managing databases to ensure only approved products are sold and supervise UDI systems.
- Maintaining regulatory systems for tracking submissions, impact assessments, and metrics.
- Review and approve engineering and manufacturing changes to maintain compliance.
- Developing instructions for use (IFU) content with support from core functional leads and review IFUs, Surgical Techniques, and promotional materials to ensure compliance.
- Supporting International Registrations for the product portfolio for all regions
- Supporting internal and external audits when necessary.
What will you need to be successful?
Were looking for someone with a Bachelors degree or equivalent work experience, preferably in a scientific or technical field, plus 2-3+ years experience in Regulatory Affairs. You should be experienced in US EU MDR regulatory requirements.
Having experience in US Regulatory Submissions, coupled with experience within the medical device industry is a huge bonus for this role in our Sports Medicine business.
The ideal candidate for this role is driven and a go-getter, capable of taking information, synthesising it, and putting it into practice effectively. Youll be guided by acting ethically, as this notion sits at the heart of our team. This role ensures that products provided to patients are safe and effective, exercising regulations with a foundation of ethics and care. Youll be a creative problem solver with strong critical thinking skills, adept at finding solutions where not everything is black and white.
You. Unlimited
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
- Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/
- Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.
- Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
- Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.
- Flexibility: Hybrid Working Model (For most professional roles).
- Training: Hands-On, Team-Customised, Mentorship.
- Extra Perks: Discounts on Gyms and fitness clubs, Salary Sacrifice Bicycle and Car Schemes and many other Employee discounts.
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