BostonRecruiter Since 2001
the smart solution for Boston jobs

Senior Global Reg Affairs Operations Job

Company: Boston Scientific Gruppe
Location: Marlborough
Posted on: April 11, 2021

Job Description:

Senior Global Reg Affairs Operations Job Date: Apr 5, 2021 Location: Marlborough, MA, US, 01752 Additional Locations: US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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 find meaningful purpose, improving lives through your life's work. Global Regulatory Affairs Operations team is looking for a dynamic, well organized individual who can be a contributing member of a global work environment. This individual will report into the Sr. Manager (Man II) responsible for sterilization, standards and Reg IT solutions. Your responsibilities include:--

  • Lead sterilization change efforts for EU on behalf of all divisional RA teams including but not limited to:
  • MDD and MDR submissions
  • Monitoring of sterilization regulatory changes and ensuring company readiness
  • Providing consultation on sterilization interpretations and RA impact to all stakeholders
  • Broaden role to include sterilization expertise in all markets outside of USA
  • Support and draft EU sterilization Notified Body (NB) questions and correspondence
  • Regular interactions with all Sterilization SME, Global RA Ops team members, sterilization project members, and periodically with Divisional and/or Country RA representatives
  • Correspondence with Notified Bodies pertaining to sterilization submission and review activities
  • Project Manage cross-divisional and/or pan-regional process efficiency initiatives, as needed
  • Lead CAPA and NCEP from initiation to completion including leading CAPA core teams, as applicable
  • Support the Product Approval pillar and quality system Steward activities
  • Own regulatory SOPs and WIs applicable to this role What we're looking for:--
    Basic Qualifications
    • 5 - 7 years of medical device, regulatory experience ideally with EU submissions
    • Experience and knowledge in medical device sterilization Ethylene Oxide (EO) and Radiation methods
    • Bachelor's degree, preferably in a scientific or engineering discipline
    • Fluent in English (oral and written) with strong oral and written communication skills
    • Ability to effectively manage multiple projects
    • Strong proficiency with Microsoft Excel, Word, PowerPoint, and databases such as PLM
      Requisition ID:--477359 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.
      Nearest Major Market: Boston
      Job Segment: Operations Manager, Medical, CAPA, Engineer, Operations, Healthcare, Management, Engineering

Keywords: Boston Scientific Gruppe, Boston , Senior Global Reg Affairs Operations Job, Other , Marlborough, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Other Jobs

CDL-A Company Driver - OTR Dry Van - Graduated Training (Concord,NH)
Description: Hiring: CDL-A Drivers for OTR Company Driving Positions. 5000 Sign on Bonus
Company: Big M Diesel Express
Location: Concord
Posted on: 04/12/2021

Navy Diver
Description: ABOUT br br Their accomplishments are epic. Their expertise is unrivaled. No other force is more intensely trained to succeed in the perilous world of underwater adventure. Each assignment they take (more...)
Company: Navy
Location: East Providence
Posted on: 04/12/2021

Residential Counselor
Description: Bay State Community Services br NEW PAY RATES AVAILABLE W/ 1000 Sign On Bonus br Programs located in Plymouth and Weymouth - 16.50 per hour br br The Residential Counselor (more...)
Company: Bay State Community Services
Location: Weymouth
Posted on: 04/12/2021

Become a storage host - part-time gig
Description: Neighbor Parking Storage Host Rent out your parking space or your garage and earn 4,000 / year We are looking for side hustlers and passive income lovers to join Neighbor as independent hostsNeighbor (more...)
Company: Neighbor
Location: Salem
Posted on: 04/12/2021

Navy Chaplain
Description: About The Navy Chaplain Corps boasts more than 800 Navy Chaplains from more than 100 different faith groups, including Christian, Jewish, Muslim, Buddhist and many others. Each Chaplain is also a Navy (more...)
Company: US Navy
Location: Concord
Posted on: 04/12/2021

Aviation Rescue Swimmer
Description: RESPONSIBILITIES br br As an AIRR, you must be prepared to enter the most treacherous conditions to provide recovery and relief for rescue missions, humanitarian assistance and operational support. (more...)
Company: Navy
Location: Taunton
Posted on: 04/12/2021

Front of Store Attendant
Description: Job DescriptionLot Associates assist customers with the loading of their vehicles and also monitor
Company: The Home Depot
Location: Taunton
Posted on: 04/12/2021

Store Associate
Description: Store Associate 387659847 Concord, New Hampshire, US, 03301 Lot Associates assist customers with the loading
Company: The Home Depot
Location: Concord
Posted on: 04/12/2021

Security Officer - Concord NH
Description: Job Description: br br Observes and reports activities and incidents at an assigned client site, providing for the security and safety of client property and personnel. Makes periodic patrols to check (more...)
Company: Securitas USA
Location: Concord
Posted on: 04/12/2021

Junior Financial Representative
Description: We're More Than InsuranceAt Mutual of Omaha, we're not afraid to step outside the box and release the potential for ultimate success. We are a Fortune 500 company that allows you to carve your own professional (more...)
Company: Mutual of Omaha
Location: Salem
Posted on: 04/12/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds