Regulatory Affairs position within lifecycle management (LCM). Dependent on the level, responsibilities include contributing to or leading impact assessments and notification plans for product lifecycle changes, assessing applicable health authority regulations, assessing regulatory risks for products (for changes), and capturing and communicating global regulatory requirements for lifecycle management. This role may also help prepare submission files and communicate with Health Authorities to ensure global approval for product lifecycle changes. They may also perform and/or assist with medical device reporting or field actions. This position may require support from senior Regulatory Affairs members and/or managers.

　　Job Duties

　　Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.

　　Perform and/or assist in the completion of the following tasks:

　　Preparation of regulatory submissions and change impact assessments for changes in products on the market (US, EU, Global)

　　Assessment of product impact analysis for regulatory assessment (all on market products).

　　Collaboration with SME’s to provide feedback and/or create supporting documentation to provide to local regulatory bodies to support change submissions.

　　Initiation, collection, and coordination of information of regulatory documents for various purposes.

　　Coordination with global/local RA counterparts to obtain product approvals and renewals.

　　Conduct research about new regulations and guidance documents.

　　Development and review of corporate and department procedures.

　　Lifecycle documentation updates (IFU, technical documents) to support annual updates.

　　Assist or participate in audits when needed.

　　Support the review of labeling.

　　Support or lead in understanding regulatory requirements and identify solutions; provide possible suggestions for implementation.

　　Ensures accurate population of databases for tracking global product registrations.

　　Ensures global contact lists and change notification tracking lists are maintained and kept up to date as changes are made.

　　Lead and/or coordinate meetings and guide discussions regarding regulatory topics.

　　Qualifications:

　　Bachelor’s degree or equivalent. Science background is preferred.

　　Specialist:

　　3+ years in regulatory affairs, medical device/IVD industry preferred.