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Job Details

Sr Regulatory Affairs Specialist Premarket Approval PMA submissions

Company name
Medtronic, Inc.

Location
Northridge, CA

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Position:

Sr Regulatory Affairs Specialist, Premarket

Approval (PMA) submissions

Location:

Northridge, CA

Bring

your Regulatory submission experience and join our Diabetes Group Regulatory

Affairs organization. The Sr. Regulatory Affairs Specialist, Premarket Approval

(PMA) submission is responsible for developing regulatory strategy, preparing

U.S. and EU submissions and obtaining approval to introduce new Medtronic

products and therapies to markets worldwide.

Careers That Change

Lives

The Diabetes

Group is working with the global community to change the way people manage

diabetes. Together, we will transform diabetes care by expanding access,

integrating care, and improving outcomes so people with diabetes can enjoy

greater freedom and better health.

Visit www.medtronicdiabetes.com

to see an overview of the products in

our Diabetes product portfolio.

For benefits information, go to www.benefits.medtronic.com

A Day in the Life

You will team with business unit Regulatory

Affairs Specialists (RAS) and international regulatory staffs to provide

regulatory support for new products/therapies; and develop strategies that

leverage opportunities and experiences across functions. Influence and inspire

alignment with business goals, internally and externally.

You will prepare FDA submissions (including IDE and PMA submissions,

amendments, and supplements) for new products and product changes as required

to ensure timely approvals and market release. Negotiate submission issues with

agency personnel; lead cross-functional team efforts to resolve potential

regulatory issues and questions from regulatory agencies; establish and

maintain good relationships with agency personnel.

You will prepare EU technical files and design dossiers for new products and

product changes to ensure timely approvals and market release. Review significant submission

decisions/content issues with EU international regulatory staff; work through

any submission issues from agency; lead cross-functional team efforts to

resolve potential regulatory issues and questions from regulatory agencies.

You will participate as a core member on development teams to provide

regulatory guidance, and develop regulatory strategies, and identify

deliverables needed; effectively communicate project plans, status and resource

requirements to both core teams and senior management; play a leadership role

in effectively planning and driving successful completion of complex cross-functional

projects.

You will provide regulatory affairs strategic and tactical support for clinical

studies including pre-market, post-market and physician initiated studies

You will maintain proficiency in worldwide regulatory requirements; monitor

changes to regulatory requirements and communicate this information to

departments within the business unit that may be affected by these changes;

establish and maintain good relationships with agency personnel.

You will monitor and interpret latest FDA regulatory environment and assess

impact to new product development projects and existing business procedures and

practice.

You will review and revise SOPs, and other company and departmental procedures

to ensure quality system compliance.

You may mentor or supervise other Regulatory Affairs Specialists (RAS), as

directed by manager.

You will travel up to 10%

Must Have:

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC

QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

Bachelor’s degree

with 4 years of regulatory experience or Advanced/Master’s degree with 2

years of regulatory experience

Experience

in healthcare industry (i.e. medical device, pharma/drugs, biologics,

biotech)

Experience in regulatory submissions (i.e. writing/developing/preparing/creating

submission for Premarket Approval (PMA) for Class III medical devices,

Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb

and design dossiers for Class III, drug or biologics submissions)

Nice to Have:

Master’s

Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related

technical field

Expertise

in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30-day

Notices, and Real Time Reviews

Experience

with regulatory support of clinical trials

Technically

savvy; must be able to discuss, understand and make decisions regarding a

wide array of engineering disciplines and complex technical/logistical

issues

Experience

in assembling facts from various areas, analyzing data, and providing

informed recommendations

Product

experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC),

Software and Implantable devices and thorough knowledge of regulatory

requirements

Good

working knowledge of FDA and international regulatory agency requirements,

ISO/GHTF standards

Regulatory

Affairs Certification (RAC)

Able

to assess changes to design, process, labeling, packaging, sterilization

and software to products in the market and under development for

Regulatory reporting

Must

be able to write clear, understandable technical documents, i.e.

regulatory documentation or scientific presentations. Ability to compile

data and summarize results

Organized,

efficient, process-oriented; high attention to detail

Effective

interpersonal/communication skills

Works

well under pressure in a dynamic timeline-driven environment

Ability

to effectively manage multiple projects and priorities

Demonstrated

Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills

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 Day in the Life 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.

Travel

up to 10%

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.

EEO

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

Company info

Medtronic, Inc.
Website : http://www.medtronic.com/

Company Profile
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Group’s products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.

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