Regulatory Affairs Consultant Lead

job summary:

• Driving a culture of Patient Safety & Quality always
• Representing and leading regulatory affairs on enterprise project teams
• Engaging in strategy with Business Unit regulatory affairs leaders and specialists to efficiently and compliantly bring products to the US market and support business growth and sustainment
• Providing regulatory expertise, guidance and direction, inclusive of potential risks and strategic opportunities, to regulatory affairs and cross functional leadership
• Evaluating proposed product modifications for regulatory impact and completing regulatory assessments
• Supporting Business Unit regulatory affairs specialists in preparation and submission of 510(k)s, including any follow up
• Supporting Business Unit regulatory affairs teams to interact with FDA in support of device clearance activities.
• Maintaining current knowledge of the development and changes to applicable laws, regulations and industry standards for the US and assist in the dissemination of this information
• Advising cross-functional teams and sharing knowledge and expertise to support development and training of Business Unit regulatory affairs teams

education: Bachelors

responsibilities:

• Bachelors degree in an engineering or life-scientific field; Masters degree preferred;
• A minimum of 10 years of experience working in Regulatory Affairs within the medical device industry;
• Extensive experience and knowledge required of 510(k) submissions
• Leading in a Matrix organization, leading cross-functional, and diverse teams with challenging goals
• Experience with negotiations and interactions with US FDA; previous experience as an FDA reviewer preferred
• Ability to write strong regulatory affairs justifications to support submission filing decisions

qualifications:

• Experience level: Experienced
• Minimum 10 years of experience
• Education: Bachelors (required)

• Regulatory Affairs / Compliance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.