Senior Advisor, Regulatory and Clinical Affairs
About the role
The Senior Advisor, Regulatory and Clinical Affairs, US is responsible for guiding regulatory and clinical strategies to ensure an optimized, successful, timely and resourceful commercialization of CZM’s global product portfolio in the United States. The individual is responsible for regulatory strategy and support of a variety of FDA submissions including pre-submissions (Q-subs), pre-market notifications (510(k)s), pre-market approval applications (PMAs) and investigational device exemptions (IDEs). In addition, they are responsible for advice and support to guide the necessary clinical research that enables the business to deliver market-changing innovations in medical devices. They have significant oversight and contribution to the design of clinical research studies in the US. They are an expert resource during the execution of these studies. They collaborate with CZM product development centers and US SSC Regulatory and Clinical teams to create strategic plans to support US (and potentially global) market approvals. This role acts as an advisor and subject matter expert for US regulatory and clinical questions, specifically interpreting US FDA’s perspective, at all levels, from senior management to single contributors; for all functions (e.g. RA, CA, RnD, Marketing/Product Management, MarCom), and for all CZM product development centers globally.
Responsibilities
- Provide input to regulatory and clinical strategies of all CZM products for the US market to ensure adequate and most efficient 510ks, PMAs, and IDEs
- Participate in strategy and management meetings, as needed to provide guidance and Agency perspective
- Demonstrated expertise in the design and implementation of complex clinical strategies to support global regulatory and market needs
- Expertise in the design and execution of clinical studies which optimize the use of clinical data for global product approvals
- Coach / train CZM organizations on US requirements (e.g. product design / design controls, clinical requirements, marketing material review et al.)
- Review product claims and plans for substantiation of those, and decide upon adequacy of claim substantiation
- Prepare and participate in meetings with US FDA
- Conclude on adequacy of promotional and educational materials for appropriate regulatory content in case of unclear aspects
- Support Product Complaint investigations, as required
- Support BIMO audits, as needed
- Drive resolutions of questions from FDA, pre- and post-market
Requirements
- Master’s degree with emphasis in the Physical Sciences, Mathematics, Statistics, or Engineering with a strong clinical foundation required
- Strongly prefer O.D., Ph.D. or M.D.
- Thought leader in the Ophthalmology and/or vision science fields and recognized for their contributions and/or publications in the field
- Fifteen (15) years of experience in an FDA-regulated environment (or 8+ years with M.D.)
- At least fifteen (15) years demonstrated experience with FDA, or working relationship with FDA (or 8+ years with M.D.)
- Direct experience working at the Agency is strongly preferred
Qualifications
- Excellent communication skills, both written and oral, and must be computer literate
- A strong background in refractive surgery, IOL technology, vision science and statistical analysis is desirable
Skills
- Expertise in regulatory and clinical affairs
- Experience with FDA submissions and clinical research
- Ability to interpret and advise on US FDA perspectives
- Strong leadership and coaching skills
- Knowledge of medical device regulations and standards
Benefits
- Medical
- Vision
- Dental
- 401k Matching
- Employee Assistance Programs
- Paid time off including vacation, personal, and sick days
Pay
The annual pay range for this position is $183,000 – $228,800. The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.
Schedule
This position is a remote role.