Senior Regulatory Affairs Specialist

Company: Medtronic GmbH
Location: New Haven
Posted on: September 16, 2020

Job Description:

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

Careers that Change Lives

The Senior  Regulatory Affairs Specialist  is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the US and International Regions. Regulatory Affairs Specialist will provide support for regulatory activities including: technical writing to support regulatory submissions, product labeling and instructions for use creation.

A Day in the Life

Help with development of US and International regulatory strategies for product submissions.

Assist in keeping company informed of regulatory requirements in the US and International Regions

Participate on Product Development teams and/or operations change control teams, providing regulatory labeling strategy, timelines, and direction

Support preparation of US and International submissions.

Ensure relevant ISO and FDA Export requirements are met, as required

Ensure relevant EU MDD requirements are met, as required

Review Change Orders and assess regulatory & labeling impact of product changes on US, MDD and/or International regulatory strategy and submissions per standard procedures

Excellent communication skills, strong documentation skills, Strong attention to details and technical Writing including authoring regulatory documentation, SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.

Review labeling, training, promotional and advertising material

Comply with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct

Review Industry sites such as FDA, NBOG, RAPS, etc.

Other duties as assigned or required

Must Have: Minimum Requirements

Minimum 4 years of medical device experience including knowledge of the US and International regulatory requirements

Or an advanced degree with minimum 2 years medical device experience including knowledge of the US and International regulatory requirements

Nice to Have

Bachelor’s degree in science, engineering or heath care related field

US and International medical device regulatory submission/approval experience, to include FDA and EU

Knowledge of FDA, EU MDD, MHLW, and TGA requirements

Experience of working with 510(k) and/or IDE and/or PMA devices

Medical Device Software experience

Product Labeling requirements and standards

RAC certification or Certificate

IDE and/or PMA experience

Product Labeling

Technical Writing

Systems Knowledge such as RA systems, Agile, SharePoint, Box or Quality Management Systems

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, New Haven , Senior Regulatory Affairs Specialist, Other , New Haven, Connecticut