Summary: Supports in the generation of Technical Files and Design Dossiers Works with cross-functional teams to deliver supporting documentation (IFU, DHF, CER, etc.) Supports and implements the global market change program Demonstrates a strong understanding of MDR requirements Supports Technical File Audits•Line Management of RA Associate
Responsibilities: (10%) Assists with preparing and communicates submission/compliance strategy document (1%) Reports compliance metrics to the RA Franchise lead/Manufacturer Lead and works with the RA Franchise lead/Manufacturer lead to plan and deliver submissions to specified timeframes. (40%) Prepares and reviews technical documentation including labeling and instructions for use and works with relevant team to resolve issues. Post finalized technical documentation to central repository. (30%) Communicates changes to global markets and provides submission deliverables. (10%) Prepares for and assists with Notified Body technical audits; responds to any deficiencies
Experience: Minimum: 3 years Regulatory experience within the Medical Device industry. Good interpersonal/communication skills are essential. Experience of providing Regulatory Advice to the business is essential. Ability to handle multiple demands in a fast-paced environment. Experience working with large and diverse groups. Strong understanding of EU medical device regulatory affairs preferred.
Competencies: Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, proven ability to influence cross-functional teams, strong planning and analytical skills.
Education: Educated to Degree level, or equivalent professional experience Licenses/ Certifications: None required, ISO auditing or RACS preferred.
Internal Number: R29124
About Smith & Nephew
Smith & Nephew supports healthcare professionals in more than 100 countries in their daily efforts to improve the lives of their patients. We do this by taking a pioneering approach to the design of our advanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems.
We have leadership positions in:
• Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders
• Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
• Sports Medicine - minimally invasive surgery of the joint
• Trauma & Extremities - products that help repair broken bones
Also in our portfolio is our robotics division!
Wherever you are in Smith & Nephew, and in whatever role, you are part of a company at the leading edge of healthcare, which is one of the most rewarding things about working for Smith & Nephew - the chance to make a tangible difference to people's lives. Our growing Robotics division offers technologically advanced, robotics-assisted products to help customi...ze reconstructive knee surgery for each patient, including our NAVIO™ Surgical System – handheld robotics platform designed to aid surgeons with implant alignment, ligament balancing and bone preparation. Looking to join a successful, growing team dedicated to a worldwide mission of improving lives? Can you see yourself accomplishing great things with a collaborative and positive team? Developing leading technologies and products in a state-of-art, brand new facility? You will be part of a very talented team that is highly motivated and passionate about our vision which simply is “Life Unlimited”.
We have around 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NY