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Regulatory Affairs Specialist, GYN (REMOTE)

Medtronic
Woburn, MA 01815 Work Remotely
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Regulatory Affairs Specialist, GYN (REMOTE)

Location:

Woburn, Massachusetts, United States

Requisition #:

210001XS

Post Date:

Feb 02, 2021


**Medtronic Overview**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


The **Minimally Invasive Therapies Group (MITG)** strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.


MITGs **SURGICAL INNOVATIONS** sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.


We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations


Medtronic is a $30.5 Billion company with 90,000+ employees in more than 160 countries.


**Position Description**


The Regulatory Affairs International Specialist is responsible for developing regulatory strategies, preparing international regulatory submission deliverables, and obtaining and maintaining approvals necessary to market products. This person works closely with in-country Regulatory colleagues to prepare agency submissions and with US Regulatory colleagues and other functional areas to provide timely responses to regulator questions in support of product approvals. Ensures all information provided to international colleagues is accurate, complete, and compliant to local requirements.


**Position Responsibilities** :


+ Define the regulatory strategy and manage regulatory submission activities for new product development activities and product maintenance for existing approved products.

+ Plan, coordinate, create, and provide deliverables to international colleagues to support new product registrations, license renewals, tender bids, and change submissions.

+ Review documents required for submissions to ensure they are appropriate for submission and meet local requirements.

+ Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.

+ Manage RAD/InSight database content to support new and ongoing International requests. Maintain database to ensure deliverables are accurate and up to date to ensure International regulatory submissions are accurate and reflect current product configurations.

+ Support document and site inspections by international auditors.

+ Interpret new and changing regulatory requirements, communicate impact to stakeholders, and develop implementation plans.

+ Interface with governmental agency on projects/products as identified by the manager.

+ Perform other related duties as assigned in support of international regulatory activities

+ Work on a schedule that allows interaction with colleagues in different time zones (must be able to attend early morning and late evening meetings)


**Basic Qualifications**


+ Bachelors Degree in health profession, science and/or engineering field,

+ Minimum two years in the medical device industry

+ Degree


**Desired/Preferred Qualifications**


+ Regulatory Affairs experience with international submissions

+ Understanding of engineering concepts, medical device development, anatomy, and medical practice

+ Experience working with technical documentation

+ Advanced degree in Regulatory Affairs

+ Strong communication skills (written and verbal)

+ Proven success managing multiple projects and priorities

+ Attention to detail

+ Advanced analytical thinking skills

+ Ability to work with various cultures and personality types; enjoy working in team environment

+ Team player who seeks to help and learn from colleagues seeing the department success as their own

+ A problem solver and critical thinker that relies on own judgment for appropriate level of decision making

+ Ability to manage small scale projects to completion within and outside of the direct department.

+ Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism

+ Proactively seeks to develop and become well-versed within in the regulatory landscape.

+ Ability for flexible work schedule due to interaction with colleagues in different time zones (must be able to attend early morning and late evening meetings)

+ Proficient in Microsoft Word, Excel, and PowerPoint


**Physical Job Requirements**


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.


The physical demands described within the Position 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. 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). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


The employee is required to be independently mobile


The employee must be able to travel independently to various Medtronic buildings/sites.


The employee is required to interact with a computer, and communicate with co-workers


The employee is required to travel by car and by airplane (20%)


**EEO STATEMENT:**


It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees


**DISCLAIMER:**


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2021-01-28 Expires: 2021-05-14
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Regulatory Affairs Specialist, GYN (REMOTE)

Medtronic
Woburn, MA 01815

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