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Senior Regulatory Affairs Specialist

Medtronic


Location:
Woburn, MA
Date:
15-12-2017
2017-12-152018-01-14
Job Code:
24249
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Job Details

Company Medtronic
Job Title Senior Regulatory Affairs Specialist
JobId 24249
Location: Woburn, MA, 01888, USA

Description
Senior Regulatory Affairs Specialist

Location:

Woburn, Massachusetts, United States

Requisition #:

16000DRA

Post Date:

Jun 20, 2017

**SUMMARY OF POSITION:**

Ensure Medtronic compliance to FDA and other international regulations. Prepare and submit regulatory dossiers to support international regulatory registrations and FDA submissions which may include device 510(k), IDEs, etc. in supporting business growth. Serve as regulatory representative on selected projects for new product development or line extension. Provide regulatory supervision on post-market product changes to maintain

**ESSENTIAL FUNCTIONS:**

+ Prepare, review and file appropriate FDA premarket submission to ensure devices are commercially available in the U.S.: 510(k)s, pre-IDEs, IDEs, or PMAs and PMA Supplements.

+ Create regulatory dossiers, i.e. technical files or Design Dossier for CE Marking; generate STED to support business access to international markets.

+ Maintain communication with regulatory agencies during regulatory submission.

+ Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.

+ Provide regulatory support for risk management activities and clinical evaluation

+ Represent Regulatory Affairs as core team member of new product development projects to drive innovation and to support Design Control process.

+ Develop Regulatory Strategies for new or modified products and assist on project planning.

+ Address questions or demands from external and internal customers

+ Collaborate with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally.

+ Prepare Regulatory Rational for product modifications without submission when appropriate.

+ Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.

+ Support Inspections by notified body, FDA and other regulatory agencies.

+ Review promotional material and labeling for regulatory compliance.

+ Monitor and provide management with impact of changes in the Regulatory environment.

**MINIMUM REQUIREMENTS:**

+ B.S. or B.A. degree required.

+ Scientific or engineering field preferred.

+ MS or MBA preferred

+ A minimum of 4 years of regulatory affairs working experience, mainly for medical devices. Must have knowledge of U.S. and/or European/International regulations and standards

+ Experience in preparing regulatory submissions; Experience interacting with FDA and/or other regulatory agencies

+ Must demonstrate good technical writing skill; Must work well in team environments; Must demonstrate good communication skill in team setting

+ Proficient on programs under Microsoft office; Proven analytical abilities; Solid understanding of manufacturing and change control, and an awareness of regulatory trends

**WORKING CONDITIONS** :

Office based, Limited Travel 5%

_In order to be considered for this position, the above basicqualifications must be evident on your resume._

**ABOUT MEDTRONIC:**

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.Let’s work together to address universal healthcare needs and
improve patients’ lives.Help us shape the future.

**PHYSICAL JOBREQUIREMENTS:**

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.

**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 at http://www.uscis.gov/e-verify/employees :// at http://www.uscis.gov/e-verify/employees 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.

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