Senior Regulatory Affairs Specialist (OTTAVA)

Job description

Job responsibilities

• Applies strategic regulatory thinking along with technical expertise to implement regulatory strategies for new product clearances and approvals.
• Prepares and submits regulatory information required to obtain global market access including preparation, writing and filing of FDA submissions including 510(k)s and global health authorities’ submissions technical…
• Proactively identifies issues, effectively communicates timelines for project completion, and addresses issues that may impact registration status.
• Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
• Assists in the development of Regulatory Affairs processes.

Job requirements

• Minimum of a Bachelor's Degree required , Advanced Degree highly desired ; desired areas of study include Science, Engineering, or related field.
• Minimum of 4+ years of related Regulatory Affairs experience within Medical Device is required ( 3+ years with Advanced Degree ).
• Experience with medical device regulatory new product submissions required .
• A demonstrated track record of developing and driving implementation of regulatory strategies.
• Working knowledge of how global regulations impact product registration.
• Good communication skills for effective collaboration with cross-functional partners.
• Corresponding and collaborating with J&J colleagues globally for strategic contribution and achievement of regulatory milestones.
• Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.