Regulatory Affairs Specialist Details

Regulatory Affairs Specialist

Medtronic - Mansfield, MA

Employment Type : Full-Time

REGULATORY AFFAIRS SPECIALIST

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Careers That Change Lives

Medtronic is seeking a Regulatory Affairs Specialist to support the Wound Management Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices focusing on a diverse line of Sutures (absorbable/non-absorbable, coated/uncoated). Regulatory support will focus on globalization, international submissions, commercial support, manufacturing support, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Wound Management business.

A Day In The Life

The Regulatory Affairs Specialist is responsible for the support of globalization efforts and maintenance of business projects under guidance by management. Specific activities include but are not limited to:

• Provide support of global product registrations with a focus on Technical Documentation and International STED
• Prepare, submit, and maintain product specific dossiers per local country requirements
• Provide support of worldwide international requests
• Review product labeling for compliance with global labeling regulations
• Review advertising and promotional literature for compliance with applicable regulations
• Interpret and evaluate proposed regulations and advise on impact of such regulations on the business
• Analyze product changes for impact to current filings. Communicate impact to teams and complete the required documentation.
• Maintain current regulatory databases and produce various reports as needed
• Maintain and provide regulatory information in support of customer queries, bid and tender submission, customs queries, etc.

Must Have; Minimum Requirements

• Bachelor’s Degree in a scientific discipline
• Minimum 2 years Regulatory Affairs experience in the Medical Device industry or minimum 0 years regulatory affairs experience in the Medical Device industry with an advanced degree.

Nice To Have

• Advanced degree in Regulatory Affair or RAC certificate
• Proficiency in US and Europe medical device regulations
• Strong organizational skills
• Ability to manage multiple projects
• Deadline conscious
• Problem solving skills
• Team oriented
• Strong oral and written communication skills
• Fluent in local language required

About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)