The Regulatory Affairs Manager 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 leadership and guidance to the Regulatory team on regulatory matters.

Responsibilities

• 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 labels, 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.


• Collaborate with Regulatory Operations to 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 of 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

Qualifications

• Minimum of Bachelors degree.


• A minimum of 4 years in IVD Regulatory Affairs with direct experience in preparing regulatory submissions including IDEs, 510(k)s and/or PMAs is required. Experience in working with medical device software requirements and companion diagnostics is a plus.


• A minimum of 7 years of related experience is required with a Bachelor's degree, OR, a minimum of 5 years of related experience is required with a Master's degree.

Preferred Work Experience:

• At least three years of experience working in regulatory affairs roles on CDx projects within the in vitro diagnostic industry.


• ROW knowledge


• Submitted ROW applications

Physical and Mental Requirements:

• Strong verbal and written communication skills.


• Demonstrated success in motivating team members to reach objectives.


• Strong influences skills and excellent interpersonal skills.


• Demonstrated PC experience with SPCXL, MS Word, Excel and PowerPoint

Knowledge:

US and EU regulatory submission requirements.

Skills: