Senior Regulatory Affairs Specialist

2 days ago

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Smith+Nephew

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healthcare • medical supplies • medical devices • wound care • orthopaedic reconstruction

10,000+

Description

• Coordinates associated registration or submissions leading to market clearance/approval • Provide regulatory direction to project teams for product development/design control related activities • Drafting, authoring and submitting PMA’s to regulatory agencies including US FDA and global regulatory authorities • Ensure regulatory compliance throughout product life cycle by assessing product changes for impact to registrations/licenses • Maintain databases as required and support regulatory compliance projects as assigned • Develops and implements regulatory strategies for new and modified products and regulatory processes and prepares submissions to obtain and maintain global regulatory approvals • Provides regulatory guidance and direction as a core team member on development and manufacturing teams, as well as compliance projects, throughout the product development life cycle • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams • Reviews and approves product and manufacturing changes for compliance with applicable regulations • Prepares, reviews, and maintains technical documentation including Design Dossiers and Technical files • Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development • Prepares for and assists with external audits such as MDSAP or Notified Body technical audits

Requirements

• Bachelor’s degree in biomedical engineering, Biological Engineering, or equivalent Life Sciences discipline • RAC Preferred • 5+ years in Regulatory Affairs with Product Development experience • Experience with implantable or novel devices preferred • 3-5 years of extensive experience in managing the premarket approval (PMA) complete submission processes • 3-5 years of Regulatory compliance, Global Submissions, 510K, Product development, Change Controls, MDR Technical Documentation (class III) creation and maintenance and process management • Knowledge of medical device product development regulations (ISO, GMP, FDA, CE, EU MDR) and design controls • Experience in Biologics, FDA Q-Sub, Internal/External Audits, Quality Systems expertise and clinical trial experience beneficial • Travel Requirements: <10%

Benefits

• 401k Matching Program • 401k Plus Program • Discounted Stock Options • Tuition Reimbursement • PTO • Paid Holidays • Flex Holidays • Paid Community Service Day • Medical • Dental • Vision • Health Savings Account (Employer Contribution of $500+ annually) • Employee Assistance Program • Parental Leave • Fertility and Adoption Assistance Program • Discounts on fitness clubs, travel and more