Senior Regulatory Affairs Specialist

·       University / bachelor’s degree or equivalent.

·       Generally, requires 4-6 years’ work experience.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

·     Leverages scientific and technical understanding of regulated products within scope of responsibility (mainly NPD/NPI) to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.

·     Compile, prepare, review, and submit regulatory submission to regulatory authorities.

·     Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division orthopedic devices.

·     Interface with Product Development to obtain necessary information for regulatory submissions.

·     Review / approve Change Requests / Notices to determine the level of change and consequent submission requirements.

·     Review/approve product labeling: device labels, brochures, technique guides, bulletins, updates, etc.

·     Prepare registration documents, medical device listings, and annual establishment registrations.

·     Respond to requests for information on import detentions.

·     Maintain regulatory database – ongoing update of database with regulatory information.

·     Assist in the development and implementation of SOPs and systems to track and manage product-associated events.

·     Develop regulatory strategies and update strategies based upon regulatory changes.

·     Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.

·     Provide regulatory input to product lifecycle planning.

·     Understand, investigate, and evaluate regulatory history / background of class, disease / therapeutic/diagnostic context in order to assess regulatory implications for approval.

·     Determine and communicate submission and approval requirements.

·     Problem-solve with and advise internal stakeholders on regulatory issues.

·     Identify standards for the organization’s products.

·     Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times.

·     Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

·     Consults with others to understand the benefits, risks, and J&J Credo-based impact associated with decision alternatives before making decisions.

·       Responsible for communicating business related issues or opportunities to next management level.

·       For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

·       Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

·     Performs other duties assigned as needed