Sr Regulatory Affairs Specialist, Premarket
Approval (PMA) submissions
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
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.
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
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
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%
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC
QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
with 4 years of regulatory experience or Advanced/Masters degree with 2
years of regulatory experience
in healthcare industry (i.e. medical device, pharma/drugs, biologics,
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:
Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related
in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30-day
Notices, and Real Time Reviews
with regulatory support of clinical trials
savvy; must be able to discuss, understand and make decisions regarding a
wide array of engineering disciplines and complex technical/logistical
in assembling facts from various areas, analyzing data, and providing
experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC),
Software and Implantable devices and thorough knowledge of regulatory
working knowledge of FDA and international regulatory agency requirements,
Affairs Certification (RAC)
to assess changes to design, process, labeling, packaging, sterilization
and software to products in the market and under development for
be able to write clear, understandable technical documents, i.e.
regulatory documentation or scientific presentations. Ability to compile
data and summarize results
efficient, process-oriented; high attention to detail
well under pressure in a dynamic timeline-driven environment
to effectively manage multiple projects and priorities
Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills
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.
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.
up to 10%
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.
want to 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.
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.
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
Website : http://www.medtronic.com/
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 Groups 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.