Principal Specialist, Regulatory Affairs

About the role

As a Principal Specialist, Global Regulatory Affairs, you will manage regulatory activities for an assigned portfolio of medical device products across the U.S., EU, and other global markets. You will develop regulatory strategies, assess product and process changes, and support submissions that maintain market access and compliance throughout the product lifecycle. Working closely with Regulatory Affairs, R&D, Quality, Marketing, and Operations, you will provide regulatory input that supports sound business and compliance decisions. In this role, you will contribute to global regulatory planning and execution for Baxter products. Success will be measured through effective lifecycle management, timely regulatory submissions and approvals, and the ability to support product changes while meeting regulatory requirements.

Responsibilities

• Manage regulatory approvals, registrations, and change assessments to support the ongoing compliance and market availability of medical device products.
• Develop regulatory strategies and submission plans to support product changes, process changes, and new market introductions.
• Evaluate regulatory impact and determine submission requirements for the U.S., EU, and other international markets.
• Prepare and submit U.S. regulatory filings, including 510(k) submissions, pre-submissions, and responses to FDA requests.
• Maintain EU MDR regulatory documentation and support updates to technical documentation.
• Support interactions with Notified Bodies and regulatory authorities for assigned products.
• Review technical, scientific, and quality information to assess regulatory impact and support implementation of product lifecycle changes.
• Monitor changes in regulatory requirements and assess potential impact to products, processes, and regulatory strategies.
• Partner with cross-functional teams and international regulatory colleagues to support global submission planning, execution, and compliance activities.

Requirements

• Bachelor’s degree in scientific or engineering subject area.
• 5 years regulatory experience in the medical device industry.
• Experience with electromechanical medical devices is desirable.
• Experience with FDA change assessment guidance and EU MDR technical documentation expectations.
• Ability to document regulatory decisions and defend submission strategy.
• Successful preparation and submission of 510(k)s.
• Familiarity with global registrations beyond the US and EU.

Skills

• Strong regulatory knowledge and ability to interpret scientific information to support regulatory submissions.
• Ability to influence cross-functional partners and drive regulatory alignment in a matrixed, global organization.
• Ability to manage multiple projects and timelines in a multinational/multicultural team environment.
• Strong oral and written communication and presentation skills.
• Strong negotiation skills.
• Identify, prioritize and communicate regulatory risks and raise issues when appropriate.

Pay

The estimated base salary for this position is $104,000 - $143,000 annually. The estimated range reflects an anticipated salary range for the position. Individual pay is based on location, skills, expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• Medical and dental coverage starting on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident.
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence, and paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.