Senior Specialist, Regulatory Affairs

Join to apply for the Senior Specialist, Regulatory Affairs role at Quest Diagnostics

Pay Range: $90,000 - $130,000 per year

• Provide regulatory guidance in product design, clinical studies, market authorization strategies, and labeling.
• Review and edit product submissions and other communications prepared by junior department members.
• Act as regulatory subject matter expert for junior department members.
• Provide pre-market and post-market regulatory strategy to ensure regulatory compliance and advance commercial objectives.
• Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.
• Prepare global regulatory applications, as well as internal regulatory file documentation.
• Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDR, Technical Documentation, ROW submissions and global product registrations.
• Independently communicate with regulatory agencies on pre-market and post-market related issues.
• Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc.
• Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.
• Monitor proposed regulatory changes from the FDA and worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment.
• Review related regulatory publications and documents to stay informed about current regulatory actions.
• Interface with industry associations to help state, federal, and international regulatory agencies develop regulations.
• Provide backup to the Regulatory Affairs Director as needed.
• Perform other duties as assigned. Provide technical and editorial direction to junior department members.

• BS/MS in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or related discipline required.
• Must have extensive knowledge of U.S, Canadian, European and other International In vitro diagnostic regulations and standards.
• At least three to five years of pre-market regulatory experience in IVD industry. Clinical research experience desired, but not required.
• Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required.
• Must be able to work well in team environment with individuals from diverse functional areas, as well as work independently.
• Must demonstrate leadership skills without having direct authority.
• Must have experience working on project/product from concept to market introduction.
• Must have proven analytical capabilities, solid understanding of manufacturing and change control, and awareness of regulatory trends.
• Must have experience in negotiation of technical issues with internal and external functions including health authorities.

• Medical/Prescription Drugs
• Dental
• Vision
• Flexible Spending Accounts (FSAs)
• Supplemental Health Plans
• 401(k) Plan – Company match dollar-for-dollar up to 5%
• Employee Stock Purchase Plan (ESPP)
• Supplemental Life Insurance
• Dependent Life Insurance
• Short- and Long-Term Disability buy-up
• Blueprint for Wellness
• Emotional Well-Being Resources
• Educational Assistance
• Paid time off / Health Time
• Variable Compensation Plans
• Sales Incentive Plans

Quest Diagnostics honors our service members and encourages veterans to apply.

Equal Opportunity

Employer:

Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.