Principal Regulatory Affairs

Medline; Northern (KY); Hybrid; USD 116,000 - 174,000; Full time

Benefits offered by this job

Bonus/incentive eligible

Job summary

Medline is seeking a Principal Regulatory Affairs professional for a remote, nationwide role. The candidate will develop regulatory strategies for global approvals, negotiate with regulators, and guide product development to ensure timely market entry and ongoing compliance.

The role requires leading cross-functional teams, driving regulatory submissions (510(k) and CE Technical Files), and monitoring regulatory changes across multiple international markets.

Qualifications

• 5+ years of diverse regulatory experience in the medical device industry, including pre- and post-market activities.
• Experience authoring and submitting regulatory filings for 510(k)s and CE Technical Files.
• Experience negotiating with regulatory authorities and leading cross-functional groups.

Responsibilities

• Determine regulatory submission requirements for clearance/approval in assigned markets (global scope).
• Lead internal and external teams to obtain supporting technical information and substantiate filings.
• Communicate regulatory requirements to internal/external stakeholders and provide strategy recommendations.

Skills

Regulatory strategy

FDA submissions

Global/regulatory

CE/Notified bodies

Regulatory intelligence

Education

Bachelor’s degree

Job description

## Principal Regulatory AffairsApply: Remote: REMOTE- Illinois: Full time: Posted Today: R2618796**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:*** NoneMedline 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 AnnualThe 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.