Principal Regulatory Affairs

Medline Industries, LP; United States; Remote; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Principal Regulatory Affairs professional to develop regulatory strategies for global product approvals and maintain existing products. The role is remote and requires leadership in negotiations with regulatory authorities, guiding major projects, and informing future product development.

Ideal candidates have 5+ years of diverse regulatory experience in medical devices, including 510(k) submissions and CE Technical Files, with strong cross-functional

Qualifications

• 5+ years of diverse global regulatory experience in the medical device industry.
• Extensive experience authoring and submitting regulatory submissions including 510(k)s and CE Technical Files.
• Ability to lead cross-functional groups and interact with regulators.

Responsibilities

• Determine requirements for product submissions and regulatory filings for clearance/approval in assigned markets.
• Communicate regulatory requirements to internal/external stakeholders and propose regulatory pathways.
• Review evidence to ensure compliance with regulations, guidance, and standards.
• Lead internal groups to maintain regulatory filings and coordinate with regulators on inquiries/non-conformances.
• Oversee development, review, and substantiation of product labeling and claims for different markets.
• Manage complex projects with timelines and cross-functional teams; identify and fix process gaps.

Skills

Regulatory experience

Regulatory submissions

Regulatory strategy

Education

Bachelor's degree in life sciences

Job description

Job Summary

Medline Industries has an immediate opening for a Principal Regulatory Affairs. This role will be remote. Responsible for developing regulatory strategies for global approvals that introduce new products to market and maintain existing products. The position is responsible for negotiating with regulatory authorities, and inform future product development. This position must function independently to resolve regulatory issues, provide direction on projects of large scale with significant business impact, negotiate with regulatory authorities, and inform ongoing project and product development. The Regulatory Specialist Principal leads work groups as a recognized expert in various and diverse area(s) of regulatory and technical competency.

Job Description

MAJOR RESPONSIBILITIES:

• In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s), including for national or multi-national launch projects. Identify and pro-vide solutions for factors that could impact the success or viability of new product launch in assigned market(s). Monitor changes in regulations that impact current or future requirements and overall compliance; actively propose and execute necessary changes to impacted procedures, products, or records. Acquire and apply knowledge of harmonized standards where applicable.
• Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, solutions, and future actions for specific and diverse scenarios, accounting for business objectives and factors relevant to other departments/functional areas.
• Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards utilized in various applicable markets that have been identified as applicable.
• Direct and take action to complete and maintain regulatory filings by leading internal groups, collaborating with external groups, providing direction to obtain sup-porting technical information, and implementing focused solutions for identified changes and challenges. Lead direct communication with critical regulators to respond to non-conformances and questions.
• Lead processes and projects involving the development, review, and substantiation of product labeling and claims where needed for various markets and projects.
• Manage complex projects by providing direction on diverse regulatory pathways, defining timelines for technical deliverables and multifaceted project teams, identifying and correcting process deficiencies, and de-fining future actions and solutions.
• Proactively review, improve, and develop regulatory-driven and technical processes.
• Propose, establish, and maintain department databases, logs, and files necessary for ensuring ongoing compliance.
• Oversee and lead internal and external au-dits and manage post-audit corrective actions.

MINIMUM JOB REQUIREMENTS:

Education:

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.

Certification / Licensure:

• None

Work Experience:

• Strong global background (5+ years) of di-verse regulatory experience in the medical device industry, including support of pre- and post-market regulatory activities, independent submissions, participating in regulatory intelligence programs, and development and implementation of regulatory strategies in multiple international markets. Sound background and ability to lead efforts related to technical fields such as risk management and design and development.
• Extensive experience authoring and sub-mitting regulatory submissions including 510(k)s and CE Technical Files. Extensive experience communicating and negotiating with regulatory agencies, including FDA and notified bodies.

Knowledge / Skills / Abilities:

• None

PREFERRED JOB REQUIREMENTS:

Education:

• None

Certification / Licensure:

• None

Work Experience:

• None

Knowledge / Skills / Abilities:

• None

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$116,000.00 - $174,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click [here](https://urldefense.com/v3/ https:/digital.alight.com/medline ;!!DjNdo6avjEs!o-bxZ6fy_WNH13q2FLYYmUMb1U4cic3ioox3ulm5dkpyivWM09cd64RN8rHuDH5AQKNiwEzHU2VbVJht5ginULSy5aJGsA$).

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging pagehere.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.