Contractual Stroke Program Manager Jobs in Wisconsin

MARS Solutions Group is looking for an experienced Program Manager I, for a client located in Wauwatosa WI, USA. Our client is a well-known Healthcare technologies and organization seeking bright, tech-savvy talent.

Client Industry: Healthcare technologies

Location: Wauwatosa WI, US

Job Type: 100% Remote (Contractor can be remote from anywhere in US but if in Milwaukee that's preferred)

Job Title: Program Manager I/Regulatory Affairs PM

Experience Level: Bachelor's degree from an accredited university or college, preferred in a Scientific, Engineering, Regulatory, Legal, or core Life Science discipline.

Nice to Have Skills: Minimum of 2 years' experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience in Quality Assurance/Design/Engineering or similar functions

Shift Time Start time may be as early as 5am and could be as late as 10pm wherever contractor sits

Essential Responsibilities:

High volume env need to have strong PM skills.
Contractor can be remote from anywhere in US but if in Milwaukee that's preferred
Contractor will have to be flexible with work hours to accommodate the global clock. Start time may be as early as 5am and could be as late as 10pm wherever contractor sits. Do not submit anyone who is not flexible with work hours.

Contractor will have to be flexible with work hours to accommodate the global clock. Start time may be as early as 5am and could be as late as 10pm wherever contractor sits.
Duties & Responsibilities:
Need a regulatory affairs staff to assist in moving site licenses for medical devices between two manufacturing sites. Work will be to assess requirements for each country, convey to the central project team, be a member of the project team, and execute these registrations Specifically, workers that directly or indirectly support services that are invoiced to GE through one of several contractual arrangements (e.g., time/materials, statement of work, purchase agreement, direct labor).
Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets
Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc.), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
Works with a cross functional team to prepare and submit regulatory submissions such as MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose of obtaining authorization for market launch.
Assesses changes in existing products to and determines the need for new / revised licenses or registrations.
Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Contributes to writing and editing technical documents.
Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions.
Ensures compliance with pre- and post-market product approval requirements
Supports regulatory inspections, as required.
Required Qualifications
Bachelor's degree from an accredited university or college, preferred in a Scientific, Engineering, Regulatory, Legal, or core Life Science discipline
A minimum of 2 years' experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience in Quality Assurance/Design/Engineering or similar functions
Strong verbal and written communication, and presentation skills, with the ability to speak and write clearly and convincingly in English
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.
Desired Characteristics
Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. A team player and collaborator.
Preferably, Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
Experience in medical device regulatory affairs
Demonstrated life-long learner; eagerness to obtain new skills and knowledge.

About MARS Solutions Group: MARS Solutions Group is an IT staffing firm with access to a wide variety of jobs at various clients across the country. We operate with the consultant's best interests in mind and align them with roles that match their skills, aspirations, and interests. MARS values our relationships with consultants. Therefore, we will stay in touch throughout the duration of the contract to ensure the job is going well and that the role meets their career development needs.