Senior Regulatory Affairs Specialist (Sports Medicine - PMA)

Life Unlimited. At Smith+Nephew, we craft 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.

In this role, you’ll play an important role in preparing and supporting both US and international regulatory submissions and strategies for our growing portfolio.

This role involves developing global regulatory strategies and leading the associated registrations or submissions to achieve market clearance or approval. You will provide regulatory guidance to project teams on product development and design control activities, ensuring compliance throughout the product lifecycle by evaluating changes for their impact on registrations and licenses.

This is ideal for an eager regulatory affairs professional who has US & EU Regulatory Submissions experience and strong PMA experience, who will implement regulatory activities to support currently marketed devices and new product development.

What will you be doing?

You’ll ensure our medical devices meet global regulatory standards and lead the preparation and review of regulatory submissions, develop strategic plans, and collaborate with international teams with launches and market expansions. Your expertise will guide our compliance efforts, influence regulatory strategies, and drive successful engagements.

• Preparing and reviewing global regulatory submissions, including US 510(k) and EU technical documentation, and support regional colleagues with international submissions for new and modified devices.
• Leading regulatory affairs on project teams to develop strategies, testing requirements, and documentation, ensuring timely regulatory approvals for product launches.
• Developing and implementing global strategies to support product releases and market expansion for products.
• Planning, leading, and supporting internal and regulatory agency audits.
• Leading and directing interactions with regulatory authorities as needed.
• Initiating and handling regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impacts on product registrations, updating as required to maintain compliance.
• Developing and maintaining company Standard Operating Procedures (SOPs) to ensure compliance with global regulatory requirements.
• Reviewing product labeling to ensure it meets regulatory requirements.

What do you need to be successful?

We’re looking for someone with a Bachelor’s degree or equivalent work experience, preferably in a scientific or technical field, plus 5 years experience in Regulatory Affairs. You should be experienced in US & EU MDR regulatory requirements.

Having experience with PMA submissions, MDR and interactions with notified bodies is a huge bonus for the role.

The ideal candidate is driven and a go-getter, capable of taking information, synthesizing it, and putting it into practice effectively. You’ll 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. You’ll 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.
• 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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