Regulatory Affairs Specialist

If you are looking for an exceptional place to work and great career growth then this is the one for you. This role reports directly to the Vice President who is a great mentor and looking to help someone learn and build their expertise in the medical device regulatory landscape.

Responsibilities encompass:

• Supervising and coordinating submissions for international product registration, monitoring the progress of internal regional regulatory endeavors, and ensuring conformity with applicable regulations and standards.
• Taking charge of Regulatory Affairs for global product registrations promptly to align with business requirements for product expansion and global presence.
• Actively collaborating with cross-functional teams, as necessary, to strategize and offer regulatory advice, services, and resources to facilitate planned product launches and market extensions.
• Orchestrating the (pre) submission and approval processes for all applications, ensuring their accuracy and relevance to regional requirements.
• Strategizing and monitoring specific product registration and renewal endeavors, maintaining consistency with portfolio priorities across registration and renewal phases, and overseeing expiration/renewal management alongside new application planning.
• Supervising relationships and interactions with Health Authorities (HAs) to ensure the company remains abreast of current and comprehensive requirements and expectations, sharing regulatory insights with colleagues to keep them informed of potential opportunities and threats.
• Participating in pertinent regulatory enhancement initiatives.

Qualifications and Background:

• Possession of a Bachelor's degree or higher in Life Sciences, Engineering, or related fields.
• A minimum of 1 year experience in Regulatory Affairs.
• Class I or Class II experience desired
• Experience and demonstrated capability in preparing US regulatory submissions such as IDE, 510(k), PMA, and technical documentation.
• Knowledge of Quality Systems requirements including QSR, ISO 13485, GxP.

Compensation is a base salary of 100-110k + bonus + stock options.