Regulatory Affairs Strategist

Overview

Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT, is seeking an experienced Regulatory Affairs Specialist to join our team. This role will support Software heavy devices and be a technical and cultural leader for the IVS Regulatory Affairs team and the Instruments RA department.

Salary

The estimated salary for this position is $120,000 - $150,000 per year, depending on experience and qualifications.

Job Description

This Hybrid or Remote role will require the successful candidate to understand, and be able to explain regulatory strategy for more complex devices as the product portfolios expand; and a person with a principal level knowledge and understanding is needed to support.

Key Responsibilities:

• Develop in-depth regulatory strategies to expedite development for products intended for higher class medical devices.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions to ensure product compliance.
• Assist in the development of regulatory strategy and updates strategy based upon regulatory changes, product claims/labeling.
• Determine requirements (local, regional, global) and options for regulatory submission, approval pathways, and compliance activities.
• Train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitor the progress of the regulatory authority review process through appropriate communications with the agency.

Requirements

To be considered for this position, you must have a Bachelor of Science in engineering or a related field and at least 9 years of working in an FDA-regulated industry. Previous experience authoring 510(k)s and other regulatory submissions is also required.

Preferred Qualifications:

• Master's degree in Regulatory Science or a related field.
• RAC (Regulatory Affairs Certification).

Benefits

We offer a comprehensive benefits package including health insurance, retirement savings plan, and paid time off. In addition, we provide opportunities for professional growth and development.

About Lifelancer

Lifelancer is a leading talent-hiring platform in Life Sciences, Pharma and IT. We connect talented professionals with exciting opportunities in these fields.