Principal Regulatory Affairs

Medline Industries, LP; Eagan (MN); In loco; USD 116.000 - 174.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) contributions

Paid time off

Descrizione del lavoro

Medline Industries, LP seeks a Regulatory Specialist Principal to develop strategic regulatory plans for global approvals and to guide products from conception through market entry and lifecycle management.

You will independently resolve regulatory issues, steer large-scale projects, and lead expert groups across diverse regulatory areas, including interactions with FDA and notified bodies.

Competenze

• Education: B.A. or B.S. in life science, engineering, regulatory science, or related field.
• 5+ years of diverse global regulatory experience in the medical device industry.
• Ability to lead technical efforts in risk management and design development.
• Extensive experience authoring and submitting 510(k)s and CE Technical Files.
• Proven experience communicating with FDA and notified bodies.

Mansioni

• Determine requirements for product submissions and regulatory filings for clearance/approval in assigned markets.
• Identify factors that could impact new product launches and propose solutions.
• Monitor regulation changes and update procedures, products or records accordingly.
• Lead internal groups and coordinate with external groups to complete regulatory filings.
• Lead communication with regulators to respond to non-conformances and questions.
• Lead labeling and claims development for multiple markets and projects.
• Manage complex regulatory projects with defined timelines and cross-functional teams.
• Proactively improve regulatory-driven processes and maintain compliance databases.

Conoscenze

Regulatory strategy development

Global regulatory experience

Regulatory submissions (510(k))

FDA communications

Formazione

Bachelor's degree in life sciences / engineering / regulatory science

Descrizione del lavoro

Job Summary

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 supporting 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 audits 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.
• 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.

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.

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.

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.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time.

If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes.

Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.

To learn more about how Medline makes healthcare run better, visit www.medline.com.

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