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Senior Regulatory Affairs Specialist

Company: Medtronic GmbH
Location: Plymouth
Posted on: September 17, 2020

Job Description:

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.

The Cardiac and Vascular Group brings all of Medtronic’s cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe

Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

The Senior Regulatory Affairs Specialist (Sr. RAS) develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market for the APV business. The Sr. RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required. Primary responsibilities include: developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables. This role focuses on regulatory support for global markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will have primary RA responsibility for multiple Class II products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.

From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world’s leading medical device company.

A Day In The Life

Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA and other worldwide government agencies. Able to write regulatory justifications to support submission filing decisions.

Leads or compiles all materials required in submissions, license renewal and annual registrations.

Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.

Interact with regulatory authorities during the development and review process to ensure submission approval.

May be included as RA Representative on project teams with members of development project teams as necessary to communicate regulatory submissions requirements and preparations according to a defined timeline.

Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

Review and approve RAC’s, RAN’s, NCR’s, product labeling and promotional materials, per company procedures, to assure compliance with regulatory requirements.

Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals with the company.

Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.

May recommend strategies for earliest possible approvals of clinical trial applications.

Other duties as assigned.

Must Have; Minimum Requirements Bachelor’s Degree

Minimum 4 years of medical device experience, with work experience in regulatory affairs

2+ years of medical device experience, with work experience in regulatory affairs with an advanced degree.

Nice To Have History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.

Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

Excellent analytical thinking skills

Ability to effectively manage multiple projects and priorities

Proven ability to lead and work effectively in cross-functional teams

Excellent written and verbal communications skills

Ability to work in matrix teams

Strong organization and time management skills

Demonstrated ability to influence based on experience, facts and data

Highly motivated and results-oriented leader

Project-management skills and experience

Presentation skills for small to mid-sized groups

Detail-oriented

Ability to be flexible with changing priorities

Submission-related word processing skills

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) Create and manage profiles for future opportunities.

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 .

Keywords: Medtronic GmbH, Plymouth , Senior Regulatory Affairs Specialist, Other , Plymouth, Massachusetts

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