Senior Regulatory Affairs Specialist

Job Description

Responsibilities:

• Support the Device Regulatory Lead in EU Medical Device Regulation (MDR) Article 117 related activities and change control assessments for combination products.
• Assist with filing preparations related to EU Notified Body Opinions.
• Perform maintenance activities related to change control assessments for combination products.
• Support the development of Ways of Working (WoW) guides for the Global Regulatory Affairs Device role.
• 6 Years' Experience with combination products, medical device regulations, and global device regulations is a plus.
• Some flexibility in rate for candidates who are a strong match.
• Candidates must have industry experience in the pharmaceutical industry, specific to device/drug experience.
• Skill set/experience to include: a combination of the
• Experience with products that include, auto-injectors, cross labeling, co-packaging kits, and pre-filled injected syringes.