Sr. Regulatory Affairs Spec - 510k (remote flexible)
Medline Industries, Inc.
Illinois
United States
Government
(No Timezone Provided)
JOB SUMMARY:
Remote work eligible except in Colorado and Connecticut.
Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. Responsible for developing solutions to re-solve complex regulatory issues and for leading multifunctional teams in high-priority projects.
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). Identify 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.
- Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, and solutions for specific products and scenarios.
- Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards.
- Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators.
- Participate in the development, review, and substantiation of product labeling and claims.
- Manage individual projects by providing direction on diverse regulatory pathways, defining timelines for tasks and project teams, and recommending future actions and solutions.
- Assist in the review and development of processes related to regulatory activities of responsibility.
- Assist in the establishment and maintenance of department databases, logs, and files necessary for ensuring ongoing compliance.
- Actively participate in internal and external audits when applicable.
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
- At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets.
- Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files.
- Experience preparing responses and communicating with regulatory agencies.
- Understanding of the current Regulatory environment and demonstrating the ability to perform within.
- Applied knowledge of FDA regulations and guidelines.
- Ability to evaluate information to determine compliance with standards, laws, and regulations.
Sr. Regulatory Affairs Spec - 510k (remote flexible)
Medline Industries, Inc.
Illinois
United States
Government
(No Timezone Provided)
JOB SUMMARY:
Remote work eligible except in Colorado and Connecticut.
Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. Responsible for developing solutions to re-solve complex regulatory issues and for leading multifunctional teams in high-priority projects.
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). Identify 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.
- Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, and solutions for specific products and scenarios.
- Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards.
- Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators.
- Participate in the development, review, and substantiation of product labeling and claims.
- Manage individual projects by providing direction on diverse regulatory pathways, defining timelines for tasks and project teams, and recommending future actions and solutions.
- Assist in the review and development of processes related to regulatory activities of responsibility.
- Assist in the establishment and maintenance of department databases, logs, and files necessary for ensuring ongoing compliance.
- Actively participate in internal and external audits when applicable.
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
- At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets.
- Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files.
- Experience preparing responses and communicating with regulatory agencies.
- Understanding of the current Regulatory environment and demonstrating the ability to perform within.
- Applied knowledge of FDA regulations and guidelines.
- Ability to evaluate information to determine compliance with standards, laws, and regulations.