Regulatory Affairs Coordinator

Scanlan International Inc. is a medical device company specializing in the highest-quality surgical instruments. Now in our fourth generation the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world. We are seeking a Regulatory Affairs Coordinator to join our organization and continue this commitment.

The Regulatory Affairs Coordinator provides operational and administrative regulatory support for Scanlan products. The position focuses on reviewing and maintaining technical and regulatory documentation managing regulatory listings and registrations and completing routine compliance activities under a supervisors direction. This role helps keep the companys product registry accurate current and active in applicable markets while supporting ongoing baseline compliance with regulatory requirements.

This position is based out of our headquarters office south of downtown St. Paul. We welcome an on-site work environment Monday through Friday. The ideal work hours for this position are 8:30AM 5:00PM but we are flexible. This position reports to the Director of Regulatory Affairs.

What Youll Do:

Technical and Regulatory Document Management 50% of the time

• Review update organize and maintain technical and regulatory documentation in accordance with established procedures and supervisor direction.
• Verify that documents are complete accurate current and filed in the appropriate controlled location.
• Collect information and coordinate routine document updates with Regulatory Affairs Quality Engineering and other internal teams.
• Track document status due dates approvals and outstanding information; communicate questions or delays to the supervisor.

Regulatory Listings and Registrations 20% of the time

• Maintain product establishment and market registration records for Class I and non-invasive Class IIa medical devices.
• Prepare routine listing registration renewal and change-notification documentation using approved information and templates.
• Monitor renewal dates and submission status to help keep product registrations and listings active and current.
• Maintain revise and upload UDI Databases including GUDID UDIMED SWISSDAMED and AUSTRALIAMED.

Routine Regulatory Compliance Support 20% of the time

• Maintain regulatory files trackers databases certificates and supporting records needed for baseline compliance.
• Complete routine checks of records and product information against established regulatory requirements and internal procedures.
• Support document collection and record updates associated with complaints CAPA post-market surveillance audits and regulatory requests.
• Escalate missing information discrepancies expiration risks and potential compliance concerns to the supervisor.

Import/Export and Administrative Regulatory Support 10% of the time

• Prepare routine export certificates supporting documentation and records using approved information and templates.
• Maintain organized records supporting applicable FDA U.S. Customs and Border Protection and international market requirements.
• Provide other routine regulatory and administrative support as assigned by the supervisor.

The Experience Skills and Abilities Needed:

Education:

• High School degree. BS/BA degree preferred.
• BS/BA degree in life sciences other related coursework or professional training in medical device regulations quality systems clinical evaluation or risk management is preferred.

Experience:

• 0-2 years of administrative/coordinator experience
• Experience in healthcare life sciences medical devices pharmaceuticals biotechnology or another regulated industry is preferred.
• Familiarity with FDA requirements international medical device regulations and document control practices is preferred.

Skills:

• Basic written communication reading comprehension and attention to detail.
• Ability to review and update technical documentation accurately in accordance with established procedures and supervisor direction.
• Basic proficiency with Microsoft Office applications and file management (MS Word Excel)
• Ability to maintain organized records follow instructions manage assigned tasks and protect confidential information.
• Ability to communicate questions issues and task status to the supervisor and work cooperatively with team members.

U.S. Work Authorization & Sponsorship

Scanlan International will not offer sponsorship or take over sponsorship of an employment visa for this position.

Compensation

We are committed to equitable and transparent pay practices. The hourly salary range for this position is $20.00/hour - $32.00/hour representing the minimum and maximum of our compensation structure. Starting pay will typically fall between these values and is determined based on factors such as relevant experience skills and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications.

Comprehensive Benefits Offerings

- Medical Dental and Vision Insurance

- Group Life Insurance

- Short-Term Disability Insurance

- Long-Term Disability Insurance

- 401(k) Plan with Company Match

- Workers Compensation

- Employee Assistance Program (EAP)

- Regular Part-Time Benefit Eligibility

- Training and Development Program

- Tuition Assistance Program

- Paid Time Off including holidays floating holidays vacation and earned sick and safe time (ESST)

How to Apply

Scanlan International Inc. accepts online applications at with disabilities who need accommodation to complete the Scanlan International Inc. application process should contact Human Resources at 1.800.328.9458 or email .

Scanlan International is an EEO employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or status as a protected veteran.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify including your rights and responsibilities please click the following link to view Federal and E-Verify posters: Experience:

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