Massachusetts Green Jobs

Senior Regulatory Affairs Specialist – Surgical Operating Unit

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

Operating Unit

Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.

With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.

Careers that Change Lives

Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success. Experience what it’s like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.

This job opening is seeking a candidate to be hybrid from our Woburn, MA office. There is no relocation assistance offered.

A Day in the Life

• Help with development of global regulatory strategies covering US, EU & international regions for change controls and new product developments.

• Works independently to ensure regulatory goals, compliance and strategic positioning of medical device(s).

• Assist in keeping company informed of regulatory requirements in the US, EU, and International Regions.

• Participate in Quality, FDA, Surveillance, MDSAP and/or other required Audits.

• Participate on Product Development teams and operations change control teams, providing regulatory support, timelines, and directions.

• Keeps abreast of regulatory procedures and/or changes and communicates regulatory compliance updates and changes to relevant teams.

• Prepare US and EU submissions.

• Ensure relevant medical device requirements (FDA, MDR, Standards, Guidance, etc.) are met, as required

• Professional interaction with regulatory agencies on defined matters.

• FDA and EU MDR experience to ensure requirements are met in relation to product scope.

• Review Change Orders and assess regulatory & labeling impact of product changes on US, MDR 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.

• 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.

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

• Ability to problem solve, influence and/or collaborate within challenging environments.

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

• Other duties as assigned or required

Must Have: Minimum Requirements

• Bachelor’s degree and 4 years of medical device regulatory affairs experience

OR

• An advanced degree with 2 years of medical device regulatory affairs experience

Nice to Have

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

• Experience of authoring 510(k) submissions

• EU and International medical device regulatory submission/approval experience

• Medical Device Software experience including Cybersecurity

• Experience of working with electronic devices including electrical safety and EMC (electromagnetic compatibility)

• Knowledge of EU MDD, MDR, MHLW, and TGA requirements

• Experience working with Q-sub, IDE, De Novo, and/or PMA

• Experience working with a minimum of EU MDD tech file or MDR tech documentation

• Experience working with EU class 3 devices

• Experience working with wireless device

• Knowledge of product Labeling requirements and standards

• RAC certification or Certificate

• Technical Writing experience

• Systems Knowledge such as RA documentation systems, Agile, Windchill, and Insight

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)

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

86000

Max Salary

129000

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.