Massachusetts Green Jobs

Principal Regulatory Affairs Specialist – Surgical

The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the current product portfolio. As a new product development (NPD) core team member, the principal specialist works directly with the NPD team from the concept phase through commercialization. The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Sustaining regulatory responsibilities include reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate.

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.

Location: The team has a strong preference for candidates to be based in Boston, MA or North Haven, CT / 3 days a week in office. We will also consider remote within the U.S.

Careers that Change Lives

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.

A Day In The Life

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations

• Prepare regulatory (eg, FDA/Notified Body) submissions for new products and product changes, as required, to ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.

• Participate in negotiations and interactions with regulatory authorities during the development and review process

• Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team

• Support international product registrations as needed

• Manage multiple projects and prioritize tasks on day by day basis to meet project schedules

• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities

• Review promotional and advertising material

• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards

• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements

• Participate in internal and external audits as needed

• Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements

• Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.

• Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.

• Provide regulatory input to product lifecycle planning.

• Provide feedback and on-going support to product development teams for regulatory issues and questions.

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

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

• Monitors and improves tracking / control systems.

• May direct interaction with regulatory agencies on defined matters.

• Additional tasks as assigned

Must Have: Minimum Requirements

• Bachelors degree with 7 years of regulatory affairs experience

OR

• An advanced degree with 5 years of regulatory affairs experience

Nice to Have

• 7+ years of medical device regulatory affairs experience

• An advanced degree in regulatory affairs or technical field such as engineering

• Experience in Pre-Sub, 510(k), De Novo, Technical File/Design Dossier, EU MDR, IDE and SiMD

• Prior direct involvement with product development teams

• Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations

• Regulatory Affairs Certification (RAC)

• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations

• Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.

• Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.

• Previous core team experience.

• Ability to compile data and summarize results

• Proficiency in FDA compliance.

• 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

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Compensation

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here .

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

Min Salary

114400

Max Salary

171600

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.