Senior Regulatory Affairs Specialist (Remote - United States)

USA SOLVENTUM US LLC; Texas; Hybrid; USD 124,000 - 171,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Health Savings Accounts

Health Care & Dependent Care Flexible

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences

Retirement Benefits

Job summary

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and drive timely product approvals across global markets. You will guide a team, coordinate with product development, clinical, and quality assurance to ensure regulatory compliance throughout the lifecycle of Restorative Healing Technologies.

The role requires extensive experience in medical device regulatory submissions (510(k), EU MDR) and audits (ISO 13485, MDSAP), with remote/work-from-home flexibility

Qualifications

• Bachelor’s Degree or higher and seven (7) years of Regulatory Affairs experience in a regulated industry.
• High School Diploma/GED and eleven (11) years of Regulatory Affairs experience in a regulated industry.

Responsibilities

• Develop and execute regulatory strategies to achieve product market authorizations.
• Lead a regulatory affairs team and coordinate with cross-functional stakeholders.
• Represent Regulatory Affairs in global business and functional meetings.
• Prepare and support regulatory submissions including 510(k) and EU MDR submissions.
• Support ISO 13485 and MDSAP audits and regulatory activities for medical devices.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Education

Bachelor’s Degree or higher

High School Diploma/GED

Master’s Degree

Job description

Job Description: Senior Regulatory Affairs Specialist

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/

The Impact You’ll Make in this Role

As a Senior Regulatory Affairs Specialist, you will lead a regulatory affairs team primarily supporting the Restorative Healing Technologies portfolio – a functional area that is a strategic growth driver for Solventum and has corporate-wide impact. This role will support teams in early and late-stage product development to advance the product through critical milestones and regulatory activities that lead to product approvals, globally. In addition, this role will support on-going product compliance throughout the device’s lifecycle. You will actively build strong relationships across stakeholders, management, and with contract organizations. You will be responsible for developing a team that has the appropriate capacity and competence to support the strategic plans of the business. You will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Developing and executing regulatory strategies to achieve new product market authorizations faster than competitors and with differentiated indications and claims.
• Managing complex decision-making among cross-functional stakeholders in areas of regulation that are complex and evolving.
• Participating in global business and functional strategic meetings and forums while representing Regulatory Affairs.
• Performing regulatory assessments and determining registration plans with the business for strategic implementation.
• Articulating global registration requirements and compiling regulatory documents according to local regulatory requirements.
• Submitting registration documents and following through on all in-process evaluations until regulatory authorization is obtained.
• Acting as the focal point for commercial support pertaining to all regulatory activities.
• Managing regulatory systems and tools to drive operational excellence, support effective data tracking, and ensure regulatory data integrity.
• Reviewing advertising and promotional materials to ensure claims are aligned with cleared claims.
• Keeping abreast of new regulations and providing necessary regulatory information, updates, and documentation to the organization.
• Supporting ISO 13485, Medical Device Single Audit Program (MDSAP), and Technical Surveillance audits.
• Supporting additional duties and completing other responsibilities or projects as assigned.

Your Skills and Expertise

To set you up for success in this role from day one, requires (at a minimum) the following qualifications:

• Bachelor’s Degree or higher (completed and verified prior to start) AND seven (7) years of Regulatory Affairs experience within a regulated industry in a private, public, government or military environment
• High School Diploma/GED (completed and verified prior to start) AND eleven (11) years of Regulatory Affairs experience within a regulated industry in a private, public, government or military environment

Additional qualifications that could help you succeed even further in this role include:

• Master’s Degree or higher in a scientific, engineering, regulatory, or quality discipline
• Three (3) years of experience preparing and/or supporting regulatory submissions, including 510(k) submissions, EU MDR submissions, or other international medical device regulatory submissions
• Three (3) years of experience supporting ISO 13485 and/or MDSAP audits
• Experience supporting regulatory activities for negative pressure wound therapy devices and/or wound care medical devices
• Experience supporting regulatory activities for absorbable wound care dressings and matrices
• Experience supporting regulatory activities for electro-mechanical devices and/or embedded or stand-alone software medical devices

Location

Work location: Remote (United States)

Travel: May include up to 10% domestic/international

Relocation Assistance: Not authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Compensation

Applicable to US Applicants Only: The expected compensation range for this position is $124,000 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience.

Benefits

• Medical
• Dental & Vision
• Health Savings Accounts
• Health Care & Dependent Care Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• Paid Absences
• Retirement Benefits

Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Legal and Compliance

Responsibilities of this position include compliance with corporate policies, procedures and security standards while performing assigned duties. Solventum is committed to maintaining the highest standards of integrity and professionalism in recruitment. Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

Company Overview

A new healthcare company with a rich history. With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges.

20,000+ employees worldwide.

Operations in 38 countries. In more than 300 offices and facilities across the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders.

Our mission: "…to harness diverse talents and perspectives from every background to not only address our customers' most urgent priorities but anticipate the needs of the future."