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Principal Regulatory Affairs Specialist

4 months ago

GondrecourtleChâteau, Grand Est, United States Boston Scientific Full time
Additional Location(s):

N/A

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.

About the role:
At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work.

In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest.

We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.


This role will be responsible for working on Boston Scientific's novel Atrial Fibrillation technology, the FARAPULSE Pulsed Field Ablation (PFA) System.

The FARAPULSE PFA System was the first PFA technology that received a CE Mark in Europe and recently received PMA approval in the US.

PFA technology has the potential to alter the future of ablation therapy on a global scale as we expand the reach of this product into other geographies and with different indications.


Your responsibilities will include:
Develops domestic and international strategies for regulatory approval of Class I, II and III medical devices
Researches and advises company on country specific international product registration and compliance related requirements
Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
Supports international regulatory partners with investigational device and commercial marketing applications
Develops and maintains positive relationships with regulatory agency staff
Technical and labeling reviews of supporting documents for inclusion in regulatory filings
Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Represents RA on cross functional projects which may include product development, manufacturing process changes, site transfers, and continuous improvement efforts
Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
Review and approval of marketing materials
Lead and/or participate in regulatory audits, as required

Required qualifications:
Minimum of a bachelor's degree
Minimum of 8 years of regulatory affairs or related experience, or 5 years' experience with an advanced degree (Masters or PhD)
Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
Able to work independently with minimal supervision
Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
Demonstrated leadership, strategic thinking, project planning, and project management skills
Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs
Strong technical, research and problem-solving skills
Able to work well in fast-paced cross-functional team environments
Ability to articulate complex ideas clearly both verbally and in writing
Demonstrated ability to develop strong relationships with regulatory agency staff
Demonstrated ability to effectively lead multiple regulatory projects and priorities
Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred qualifications:
Bachelor's Degree in life sciences, engineering, or related field
Previous experience in the medical device industry with Class II or III device submissions
Experience working directly with FDA, notified bodies and/or international health authorities
Prior experience with electrophysiology and/or medical electronic equipment products

Requisition ID:

581430


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 prohibited substance free workplace. Pursuant to Va.

Code § , 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.

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