Sr. Regulatory Affairs Specialist

General Function

Drive Global implementation and customer deliverables for Reusable Pen platform per PS RA team Strategy

Main Responsibilities

• Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager
• Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
• Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market
• Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation
• Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders
• Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance
• Identify ways to improve the efficiency of current work process and best practices as necessary.

Education

• B.S. degree in a technical discipline (e.g., pharmacy, engineering, biology, chemistry). Advanced degree preferred.

Experience

• Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)
• Medical device and international registration experience is a must. Combination Products knowledge or experience is a plus.

Interpersonal and Social Skills

• Strong project management and communication (verbal, written) and skills
• Able to independently handle multiple tasks/projects with minimum supervision
• Self-starter with the ability to take over responsibilities
• Team player, Attention to details, Highly result-oriented
• Flexible and reliable personality; ability to manage stressful situations
• High personal integrity and ethical standards
• Ability to drive and maintain favorable customer experience and customer-centricity (internal & external)