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Specialist, Sr Reg Affairs Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Arden Hills, MN, US, 55112

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:
The Senior Regulatory Affairs Specialist will provide hands-on regulatory affairs support for Preventice new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies, preparation of submissions and representation of Preventice products with US and international regulators to ensure compliance with required regulations and established corporate standards. 

 

Your responsibilities will include:

  • Define worldwide regulatory requirements necessary for regulatory approval of assigned products.
  • Work with project teams to complete regulatory evaluations, develop strategies and execute project plans to support all regulatory aspects of new product development and product modifications.
  • Ensure regulatory change control processes and supporting documentation meets organizational needs, follows internal QMS procedures and adheres to external regulatory requirements.   
  • Provide direction on application of external standards for assigned projects as required.
  • Execute product submission strategies as needed and directed.
  • Maintain regulatory documentation to ensure availability for audits and submission packages.
  • Exercise creativity/innovation with expectations of independent research, clinical studies and the use of accepted regulatory practices in the execution of tasks.
  • Rigorous documentation for all phases of regulatory submissions, including priority setting, requirements research, documentation gathering, submission writing, approvals, renewals, and change orders.
  • Understand current and evolving regulatory submission requirements for international regions, including, but not limited to US, EU, Canada, and Australia.
  • Advise and train project teams regarding new, existing or changing regulatory requirements.

 

Required qualifications:

  • Minimum of a Bachelor’s degree in Science, Engineering, or a related discipline.
  • Minimum of 5 years’ experience in Regulatory Affairs, or a related field (Quality, Clinical, R&D, Biocompatibility, etc.), within the medical device, pharmaceutical, or health care industry
  • Working knowledge with quality systems regulations and guidelines.
  • Working knowledge of US, EU, and/or international regulations for medical devices
  • Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.
  • Working knowledge of medical devices, procedures and terminology.
  • Demonstrated capacity for intense concentration in order to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to processes, policies, procedures and other quality related documentation, which may involve point-by-point comparisons.
  • Detail orientation, aptitude to balance multiple priorities, and ability to conform to shifting priorities, demands and timelines.
  • Ability to work successfully in an environment that is deadline sensitive with frequent high-pressure situations.
  • High level of planning and organizational skills.
  • Excellent analytical skills coupled with a high level of responsibility and accuracy.
  • Ability to travel 1 to 5 times annually for 1-3 days duration.
  • Proficiency with Microsoft Office.

 

Preferred qualifications:

  • Minimum of 3 years’ experience in medical device industry.
  • Minimum of 5 years’ experience working in Regulatory Affairs.
  • Prior experience with software as a medical device
  • FDA, Health Canada, TGA, EU, and international market submission experience.
  • Demonstrated ability in project management skills in order to plan, conduct and implement system assessments and robust submissions.
     

 

Requisition ID: 532748

 

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.


Nearest Major Market: Minneapolis

Job Segment: Medical Device, Compliance, Regulatory Affairs, Pharmaceutical, Medical Research, Healthcare, Legal, Science

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