Senior Regulatory Affairs Specialist

Welcome to Medline Industries, a leading manufacturer and distributor of medical products and solutions. We are currently seeking a highly skilled Senior Regulatory Affairs Specialist to join our team and help ensure compliance with all regulatory requirements. As a Senior Regulatory Affairs Specialist, you will play a crucial role in ensuring the safety and efficacy of our products, as well as maintaining our reputation as a trusted and reliable healthcare partner. This role requires a detail-oriented individual with extensive knowledge of regulatory guidelines and a strong ability to navigate complex processes. If you are passionate about making a difference in the healthcare industry and have the necessary qualifications, we would love to hear from you.

1. Develop and implement strategies to ensure compliance with all relevant regulatory requirements.
2. Stay up-to-date with all regulatory guidelines and changes in the healthcare industry.
3. Review and evaluate product labeling, marketing materials, and promotional activities to ensure compliance with regulations.
4. Collaborate with cross-functional teams to ensure that products are developed, manufactured, and marketed in accordance with regulatory requirements.
5. Prepare and submit regulatory submissions, such as 510(k) applications, for product approvals.
6. Conduct audits and inspections to ensure compliance with regulations and company policies.
7. Respond to regulatory inquiries and requests for information in a timely and accurate manner.
8. Provide guidance and training to team members on regulatory requirements and processes.
9. Develop and maintain strong relationships with regulatory agencies and industry organizations.
10. Participate in the development and improvement of internal processes and procedures related to regulatory affairs.
11. Identify and communicate potential regulatory risks and provide recommendations for risk mitigation.
12. Assist with the preparation and execution of clinical trials and studies.
13. Conduct post-market surveillance activities and report adverse events as required.
14. Keep accurate and organized records of all regulatory activities and submissions.
15. Represent the company in meetings with regulatory agencies and industry associations.
16. Continuously monitor and assess the impact of changing regulations on the company's products and processes.
17. Adhere to all ethical and legal standards in all regulatory activities.

According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Northfield, IL, USA is between $85,000 - $120,000 per year. However, this can vary depending on factors such as education, experience, and specific job responsibilities. Some companies may offer higher salaries for this position, while others may offer lower salaries. It is important to research the specific company and their salary ranges before applying for a Senior Regulatory Affairs Specialist position.

As the nation's largest privately held manufacturer and distributor of quality medical supplies and services, Medline offers healthcare products and services that drive value through tailored solutions across the continuum of care. Medline offers 550,000+ medical supplies to improve care and help make healthcare affordable for all. As a global company made up of clinicians, researchers, engineers, financial experts and 1,400 direct sales representatives, we know the healthcare business from the bottom up and aim to serve as our customers' trusted advisers. We understand that it's not just medical products, but people's health. Our goal is to help the people who take care of patients and their loved. If you've ever been in a hospital, nursing home, or doctor's office, you have likely used our products—from the baby blanket that brought your newborn home, to the bandage that covered a scab, to the gowns, gloves and surgical procedure trays found in the operating room.