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Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

At Smith+Nephew we are looking for: Senior Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for representing and supporting the regulatory activities in EE Export Markets (CEE region).

What will you be doing?

Regulatory Submissions and Strategies: Prepare regulatory submissions and collaborate with BU regulatory teams to develop and execute global regulatory strategies, testing requirements, and documentation to meet product launch timelines in all identified marketsRegulatory Product Lifecycle Management: Manage the regulatory product lifecycle, including license renewals, discontinuations, changes, and communication with BU and commercial teams to ensure compliance and product availabilityRegulatory Project Leadership: Serve as the Regulatory Affairs (RA) lead on project teams, managing regulatory-driven projects, and ensuring successful execution of market expansion activities for new and modified productsRegulatory Compliance and Knowledge Maintenance: Maintain a working knowledge of global regulations, standards, guidance documents, medical devices, medical terminology, and country-specific requirements to ensure ongoing complianceAudit and Regulatory Authority Engagement: Plan, lead, and support internal and regulatory agency audits while managing engagement and communication with regulatory authorities as neededChange Impact and Labeling Compliance: Assess the impact of regulatory changes on product registrations, update registrations as required, and review product labeling to ensure compliance with regulatory requirementsSOP Development and Training: Develop and maintain Standard Operating Procedures (SOPs) for regulatory compliance and provide technical guidance, training, and mentoring to Regulatory Affairs employees and cross-functional teams

What will you need to be successful?

A minimum of 5 years of regulatory experience within the medical device industry, with expertise in product lifecycle management and processesIn-depth knowledge of regulatory requirements, including Medical Device Regulation (EU) 2017/745, ISO 9001, and applicable laws of non-EU export marketsProven experience collaborating with large cross-functional teams and diverse groups to achieve regulatory objectivesStrong interpersonal and communication skills, including technical writing, active listening, and effective speakingHigh learning agility with a strong analytical approach to problem-solving, enabling quick assessment and resolution of regulatory challengesSelf-motivated, solution-oriented mindset with the ability to manage multiple priorities in a fast-paced environmentExpertise in reading, understanding, and applying regulations, with the ability to write detailed technical submissions, reports, and correspondenceConfidence in responding to regulatory agency inquiries both in writing and in person

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 our Employee Inclusion Groups on our website

Your Future: annual bonus, life insurance, company stock saving plan

Work/Life Balance: paid volunteering hours, flexible approach

Your Wellbeing: private health care with dental care package, multisport card/my benefit platform

Flexibility: possibility of working in hybrid model

Training: Hands-On, Team-Customized, subsidies for language classes, certifications and postgraduate studies

Extra Perks: referral bonus, recognition program, mentoring program

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#LI-HYBRID

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