Senior Specialist, Regulatory Affairs

The Sr. Specialist, Regulatory Affairs will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. Additionally, this individual will provide input to the Regulatory or cross-functional team on regulatory matters.

Preference will be given to someone residing close to one of our Major labs in (Clifton, NJ; Pittsburgh, PA; Houston, TX; Lenexa, KS; Marlborough, MA; Dallas, TX; Wooddale, IL; Tampa, FL; Chantilly, VA; San Juan Capistrano, CA)

Internal Grade: 49

***No sponsorship available***

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

Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects - physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

* 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

• Plans and prepares regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports with moderate supervision. Ensures regulatory submissions are prepared and processed in a proactive and timely manner.
• Evaluates proposed changes for regulatory impact with minimal supervision.
• Responsible for regulatory review of protocols, reports and data for conformance with the requirements and expectations of health authorities.
• Responsible for regulatory review of labeling, advertising and promotional materials.
• Maintain knowledge base of existing and emerging regulations, standards, or guidance documents and provide interpretive assistance to cross-functional teams.
• Compile and review regulatory submissions for completeness and quality. Ensure that submissions are in conformance with the latest industry and health authority submission standards.
• Assist with logging, tracking and filing correspondence and submissions to/from regulatory authorities and ensure that no commitment remains unduly outstanding.
• Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs.

Required Work Experience:

• A minimum of 5 years of experience in a regulated industry. Three-four years of domestic/international regulatory submissions experience required.

Preferred Work Experience:

• Experience with IVDR / IVD PMA submissions preferred.

Skills:

• Ability to read and analyze and interpret technical procedures or governmental regulations.
• Ability to effectively communicate information, issues and resolve problems/conflicts in a project team setting.
• Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists.
• Ability to handle multiple projects and prioritize tasks/deliverables.

Education:

BS degree required.