Sr. Regulatory Affairs Specialist



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Based on Experience

No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description

Our client is seeking a Regulatory Affairs Specialist to be responsible and accountable for executing regulatory affairs (RA) activities to support all product lines and business initiatives. Client manufacturers class II devices and is looking for someone with MDD to MDR experience as well as some post market compliance. This is a direct hire opening located in Plymouth, MN.

Job Responsibilities:

* Ensure company products and operations comply with applicable regulatory standard requirements including FDA, EU MDR/MDD and ISO 13485 requirements.

* Lead and manage RA tasks to support achievement of business objectives and serve as RA subject matter expert.

* Collaborate closely with client's cross-functional stakeholders to achieve enterprise business objectives.

* Meet defined goals and objectives through own initiatives, activities, and available resources with minimal supervision.

* Monitor international regulatory changes and communicate appropriate information and actions throughout the company.

* Identify, understand, and apply worldwide regulatory laws and regulations to our business.

* Update and remediate historical regulatory technical documentation and strategies to meet current standards and/or to align with current leadership philosophy.

* Provide guidance and support to the post-market compliance team in activities such as vigilance reporting, medical device reporting, no-reporting determinations, complaint handling and product recall activities

* Provide support for OEM business partners regarding customer requests

* Direct development and execution of regulatory strategies. Negotiate favorable outcomes with FDA, EU notified body and international regulatory agencies. Provide leadership, guidance, strategy and manage regulatory activities in collaboration cross-functional stakeholders matrix organization.

* Review and determine regulatory implications of product, labeling and/or other documentation or design changes.

* Facilitate achievement of business objectives while ensuring compliant operation within the flexibility of the regulations.

* Participate on project teams and business group teams to provide regulatory leadership and input. Provide recommendations for how to overcome regulatory barriers and resolve any conflicts within teams as to the need for and importance of regulatory requirements.

* Lead and manage execution of pre-market strategic regulatory and product development activities.

* Direct and enable compliant, efficient, and risk-based execution of pre-market regulatory strategy and associated processes, core strategic submissions (510(k)/IDE, EU MDR, Canada, AU TGA), medical device files, labeling and regulatory intelligence processes.

Position Qualifications:

* Bachelor's Degree in a scientific, engineering, or related technical discipline

* 5 years of experience within the regulatory/compliance discipline in the medical device industry