Senior Consultant, IVD Regulatory Affairs

Position Summary:

The Senior Consultant applies expertise and in-depth knowledge of science, regulatory affairs, and product development to coordinate and execute strategies for approval of new medical devices and personalized medicine products.  Specifically, they are responsible for the implementation of high quality programs that adhere to all regulatory specifications and meet customer expectations and goals.

Essential functions of the job include but are not limited to:

Regulatory Submissions and Compliance

• Prepare regulatory submissions and other documentation as required for global clearance/approval of significant risk medical devices, including the preparation of reports and interaction with regulatory officials as required
• Review product labeling and promotional literature for regulatory compliance
• Research and interpret regulations, guidelines and precedents to support project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies
• Identify and collaborate with external thought-leaders and technical experts required to support research and development, regulatory authorization, and marketing.
• Prepare regulatory communication, submission, timeline and approval requirement documents for assigned programs and other initiatives

Consulting Services

• Provide research and analysis to support for top tier consulting engagements, including:
• Advice regarding regulatory strategy for new products and line extensions, including consideration of reimbursement requirements and the competitive environment
• Prepare for pre-submission interactions with Federal Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER) and/or the Center for Biologics Evaluation and Research(CBER), including the preparation of briefing documents, meeting materials and attendance at FDA meetings
• Respond to deficiency letters
• Create and submit IDEs, 510(k)s, and Premarket Approval Applications

Business Development

• Support management team in marketing initiatives, including workshops, publications, and conference attendance.
• Collaborate with the business development account management team to convert new business prospects into awarded and contracted business by:

-Participating in general capabilities presentations

-Attending client meetings

-Partaking in client teleconferences

-Preparing proposals

• Proactively identify client needs and develop solutions by gaining an understanding of the client’s product, the brand objectives and other relevant industry trends
• Stay abreast of the latest regulatory and scientific developments in the marketplace that will impact the line of business by identifying market trends, paradigm shifts, etc.

Administrative

• Maintain standardized start-up procedures for new programs and consulting engagements by creating regulatory check-lists, customized hot sheet, etc.
• Ensure quality and integrity of all client work products and engagements, consistent with corporate standards
• Develop and guide support staff to ensure a scalable model within the Regulatory practice as a whole

Qualifications:

Minimum Required:

• Bachelor’s Degree in a life science or equivalent work experience
• 4 years’ experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment.

Other Required:

• Direct experience preparing submissions and regulatory strategy plans for FDA approval/clearance of medical devices.
• Direct experience working with cross-functional teams of subject matter experts.

Preferred:

• Master’s Degree in a life science
• Experience managing staff members preferred

Skills:

• Strong written and verbal communication skills
• Strong interpersonal skills
• Strong business and financial acumen
• Strong scientific and analytical skills with close attention to detail
• Ability to work well under pressure and meet deadlines
• Ability to think outside of the box and solve difficult problems with effective solutions