Principal Regulatory Affairs Specialist

Working for a company voted Great Places to Work - 2022, the Principal, Regulatory Affairs Specialist is responsible for preparing strategy for worldwide product approval submission activities, responsible for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral medical devices.

What You'll Be Doing

Working with R&D and Manufacturing to lead design control activities for the development and manufacture of medical devices. . Job duties:

• Represent Regulatory on project teams and partner with project team to ensure alignment of global regulatory strategy with the team objectives
• Identify regulatory requirements for the markets identified and work independently in developing global regulatory strategy for assigned projects and develop approaches to solutions
• Coach, review and delegate work to junior regulatory affairs professionals; may manage large projects and processes that span outside of immediate job area
• Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy
• Communicate with regulatory agencies on administrative and routine matters
• Document, consolidate, and maintain verbal and written communication with the regulatory agencies
• Review change order documents and ascertain impact on current regulatory approvals
• Review promotional material and labeling for regulatory compliance
• Develop and maintain regulatory files and records
• Support and contribute into developing, editing, or revising regulatory processes
• Lead training for global regulatory processes and system implementations
• Build team cohesiveness by influencing and mentoring team members
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization

The Skills/Experience Needed for the Role

1. Bachelor’s degree in a scientific or technical discipline or relevant field of study
2. Seven (7) to ten (10) years of professional regulatory experience
3. Strong technical writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions, including clinical investigation submissions (e.g. IDE)
4. Prior direct involvement interfacing with regulatory authorities through regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review
5. Detail oriented. Strong written and verbal communication skills

How to Stand out from the Crowd

1. Advanced degree in a scientific or technical discipline or relevant field of study
2. Direct experience with product development of active implantable device with software and/or electrical/electromechanical testing (IEC60601 standard series), software validation (ISO62304).
3. Experience in leading large sized project teams across multiple product lines
4. Proven technical abilities, analytical abilities and organization skills.
5. Ability to comprehend technical documents and concepts

Salary Range

$92,341 - $138,972 (Compensation could be higher based on education, experience and skill sets)

MicroVention Perks

• 15 Days of PTO, 12-13 Paid Holidays, and offices closed last week of December (paid).
• Tuition Reimbursement up to $10,000/Year
• On-Site/Hybrid/Remote Work Schedules
• Focus on Diversity, Equity & Inclusion (DE&I)
• Comprehensive Learning & Development Programs

We are an equal opportunity employer (EOE) and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.