Manager, Regulatory Affairs ( Medical Device )
InnFocus, Inc., based in Miami, FL with additional employees in Emeryville, is working to provide a safe, effective, and intuitive device for the surgical treatment of glaucoma. Our lead product, the InnFocus MicroShunt® Glaucoma Drainage System, is a glaucoma drainage implant that is producing promising and sustained clinical results in clinical investigations and in early commercialization.
With the passionate support of our Japanese parent company and its 125-year heritage, Santen is pursuing intellectually-challenging and stimulating technologies to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.
We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.
We are in search of top talent to help us meet our aggressive and important goals.
PRIMARY PURPOSE OF POSITION:
Manage the Regulatory Affairs function. Oversee submission processes including preparation of CE Mark documentation, PMA supplements, IDEs, document packages for foreign marketing applications, export licenses, etc. Responsible for providing regulatory review of labeling and promotional materials. Responsible for MDR/vigilance reporting and field actions (recalls, advisory notices, etc.) regarding non-conforming product.
MAJOR DUTIES OF POSITION:
- Oversee updates to Technical File and other documents required for CE Marking.
- Communicate with Notified Body as necessary regarding changes to CE-Marked product or related manufacturing processes
- Prepare PMA Supplements
- Prepare IDE submissions
- Prepare export license submissions
- Prepare document packages for use by worldwide Santen regulatory groups in obtaining local marketing approvals.
- Review product labeling for regulatory compliance
- Review marketing materials for regulatory compliance
- Participate in MDR/Vigilance reporting process with Santen Pharmacovigilance, and submit reports as required
- Interact with stakeholders to define submission logistics and scheduling, and to coordinate priorities for submissions
- Identify new regulations and track revisions to current pertinent regulations; update submissions to regulatory authorities, and advise/educate other functions regarding regulations.
- Perform other duties as necessary, as assigned by management.
KNOWLEDGE, SKILL, AND REQUIREMENTS:
- BS required (preferably in a relevant discipline) with a minimum 5-8 years of related experience in medical device industry with 5+ years in Regulatory Affairs.
- Management of document control specialists.
- Strong understanding of FDA and EU regulations and submission process
- Proficiency with word processing software and general knowledge of spreadsheets and other relevant software
- Ability to anticipate, communicate, and resolve problems
- Excellent verbal and written communications skills required
- Ability to interact successfully with multiple cultures.
- Ability to interface cross functionally to produce quality submissions
- Considerable time spent at a computer
- Must be able to work in a fast-paced working environment managing multiple tasks
- Must be willing to travel