Principal Regulatory Affairs Specialist

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

We as Boston Scientific are expanding our Regulatory Affairs team in Israel ( Yokneam) due to our growth and the acquisition of Lumenis Israel- Medical Lasers.
That's why we are recruiting for a Principal Regulatory Affairs Specialist 

About this role as Principal Regulatory Affairs Specialist- Israel:

Responsible for Regulatory Affairs support of submissions and on going regulatory compliance for product development process.

Your key responsibilities will be:

• Reviews and signs-off on product design control documentation for compliance with applicable regulations.
• Provides technical/regulatory guidance to cross-functional teams.
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
• Develops and implements regulatory strategies for modified products.
• Acts as a core member on manufacturing and remediation teams, providing regulatory feedback and guidance throughout the program, and coordinating team inputs for submissions.
• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
• Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.  Ensure employees are trained to do their work and their training is documented.

Who are we looking for:

• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
• 8+ years Regulatory Affairs experience, medical device experience required
• Working knowledge of design control documentation/requirements required
• Working knowledge of FDA and international regulations
• General understanding of product development process
• Working knowledge of regulatory requirements for implantable, capital equipment and single use disposable devices
• Ability to manage several projects
• Proficiency with Microsoft Office
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision
• Language skills: English and Hebrew

Quality System Requirements:

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.
   

Requisition ID: 532619

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.