Sr. International Regulatory Affairs Specialist

Custom Search Inc.

Share:

Details:

Job Type:

Direct Hire

Remote Status:

Hybrid

Apply Later:

Send this job to your inbox!

Sr. International Regulatory Affairs Specialist

Minneapolis, MN

ID11795Posted 10/7/2024

Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team! The Sr. Regulatory Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Sr. Regulatory Affairs Specialist will perform regulatory submission/approval activities for all products and ensures compliance with required regulations and established corporate standards.

Your role with the company:

Preparing documentation for international regulatory registrations
Preparing technical documentation compliant with regulations
Defining worldwide regulatory requirements necessary for regulatory approval of products
Participating on cross-functional teams as regulatory lead
Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages
Authoring submissions, researching requirements, setting priorities, and maintaining project schedules
Providing guidance and oversight to team members related to regulatory compliance
Act as a Subject Matter Expert (SME) to support internal and external audits

Desired Profile:

Bachelor’s Degree in Science, Engineering, or other relevant discipline
Minimum 8 years’ experience in Regulatory Affairs in the medical device industry
FDA, EU, Health Canada, and international registrations experience
Working knowledge of quality system regulations and guidelines
Ability to develop clear, concise, and timely oral and written reports
Great communication skills with all levels of personnel
High level of organization and planning skills
Working knowledge of medical devices, procedures, and terminology

Upload Resume*

First Name *

Last Name *

Email

Phone

Create a Job Alert

Get notified about new listings!

Submit a Resume

Can't find the job you want?

Submit a general application

Principal Systems Test Engineer

Minneapolis, MN

Direct HireOn-Site

Our mid-sized cardiovascular medical device client is seeking a permanent Principal Systems Test Engineer to join their team. This is a key technical leadership role responsible for leading the development and execution of comprehensive testing strategies. Responsible for evaluating, developing, and implementing test systems/tools/equipment, including design documentation. The position will provide Verification and Validation expertise to new product introduction of electro-mechanical, software-controlled medical devices. This role requires a deep understanding of medical device systems, strong leadership abilities

Upstream Clinical Program Manager

Minneapolis, MN

Direct HireRemote Available

Our mid-sized medical device client is adding an Upstream Principal/Sr. Clinical Program Manager to the team. This is a fantastic opportunity to work on cutting-edge breakthrough technology and start an IDE from scratch! The Clinical Program manager will integrate with R&D during product development for new device indications and will partner with Regulatory, Marketing, and R&D to design pre-market feasibility and pivotal clinical studies to satisfy regulatory requirements and support marketing claims. This

Sr/Principal Product Development Engineer

Our mid-sized medical device client is looking for a seasoned engineer. The Product Development Engineer III with a mechanical focus, is responsible for development and implementation of new products, developed jointly with Process Development and Manufacturing Engineering, into full production, as well as supporting of continuation engineering on existing product lines. The role will be about 70% Project Management with about 30% technical. Your role with the company: Product Concept: *Basic understanding of customer/user and patient needs. *Proposes concepts

Sr. Design Assurance Engineer

Minneapolis, MN

Direct HireOn-Site

Our mid-sized medical device client is adding a Sr. Design Assurance Engineer to the team! The Sr. Design Assurance Engineer utilizes risk management and quality planning activities to provide quality engineering support of product/process development and input to Quality Management Systems affecting product/process development. Champions departmental or cross-functional engineering initiatives and acts as an effective leader or team member in supporting quality disciplines, decisions and practices. Your role with the company: Key member of medical device development project

Principal Electrical Engineer

Minneapolis, MN

Direct HireOn-Site

Our mid-sized cardiovascular client is adding a Principal Electrical Engineer to the team. The EE will play a key role in supporting and improving designs of innovative medical devices. This is a technical, hands-on engineering position that works as an integral member of the design-sustaining team. In this role, you will utilize data to identify opportunities, lead projects, and implement changes focused on improving product performance and reliability, product enhancements, and component obsolescence. You'll be a

Sr. R&D Sustaining Engineer

Minneapolis, MN

Our mid-sized medical device client is adding a Sr. R&D Sustaining Engineer to the team. This is a newly created position reporting to the Director of Quality. The Sr. R&D Sustaining Engineer will primarily maintain existing commercialized products post-transfer by ensuring the products remain safe, compliant, and optimized for manufacturing process performance. The role is critical in driving continuous improvements to existing products to ensure they meet or exceed internal and external requirements. Experience

Sr. Clinical Research Associate

Direct HireHybrid

Our small start-up client is adding 2 (Sr.) Clinical Research Associates (CRA) to the team. The CRA works as part of the clinical team to ensure the completion of company-sponsored clinical studies. As an internal and externally facing position, this position interacts directly with the internal study team, clinical vendors, clinical Investigators, and other study staff at a clinical research site. The CRA will be the primary contact for the study sites regarding the proper execution of the

Clinical Project Manager

Minneapolis, MN

Direct HireFull Remote

Our small, well-funded start-up client is adding a Clinical Project Manager to the team. The Clinical Project Manager will report to the VP Clinical (lives in MN) and will be a remote role with minimal travel. The Clinical Project Manager leads the planning, development and execution of the clinical research trial(s). Ensures compliance to study protocol, Good Clinical Practices, applicable domestic and international regulatory standards, and Standard Operating Procedures. The Clinical Project Manager will participate in development

Clinical Study Manager

Minneapolis, MN

Our mid-sized medical device client is adding a Clinical Study Manager to the team! The Clinical Study Manager will report to the Sr. Clinical Manager and will oversee clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager will work independently on multiple complex clinical studies using critical thinking skills. Will be managing one study in start-up and another on-going study. The new

Sr. International Regulatory Affairs Specialist

Minneapolis, MN

Direct HireHybrid

Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team! The Sr. Regulatory Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Sr. Regulatory Affairs Specialist will perform regulatory submission/approval activities for all products and ensures compliance with required regulations and established corporate standards. Your role with the company: Preparing documentation for international regulatory registrations Preparing technical documentation

Clinical Research Associate/Sr. CRA

Minneapolis, MN

Direct HireHybrid

Our mid-sized medical device client is adding a Sr/Clinical Research Associate to the team. The Sr. CRA is responsible for the initiation and oversight of clinical centers to ensure the successful conduct of active clinical studies. The Sr. Clinical Research Associate will ensure that clinical centers perform the clinical study according to the study protocol and regulatory standards by qualifying, training, monitoring and overseeing study conduct at multiple clinical centers. Your role with the company: Identify and assess the

Regulatory Specialist

Minneapolis, MN

Direct HireHybrid

Our mid-sized client is adding a Regulatory Affairs Specialist to join their team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific products and ensures compliance with required regulations and established corporate standards. Your role with the company: Preparing documentation for international regulatory registrations and renewals. Defining worldwide regulatory

Director of Electrical and Software Engineering

Our smaller medical device client is adding a Director of Electrical and Software Engineering to lead an engineering team in creating groundbreaking solutions. The Director of Electrical and Software Engineering will play a pivotal role in driving the development and implementation of electrical and software systems for innovative medical devices. This leadership position requires a seasoned professional with a proven track record in both electrical and software engineering, as well as a deep understanding of regulatory requirements within the medical

Sr. Quality Engineer

Minneapolis, MN

Direct HireOn-Site

Our mid-sized medical device client is adding a Senior Quality Engineer to the team! The Sr. QE will have the opportunity to be a key team member in supporting a medical device from transfer to manufacturing through commercial distribution. They are responsible for ensuring a smooth transition of new products to the manufacturing floor with the assistance of a cross-functional team. They will maintain oversight of all manufacturing activities and be responsible for the final release of sterile

Loading Jobs...