Sr. Regulatory Affairs Specialist

2 weeks ago

Marlborough, United States Boston Scientific Full time

Recruiter: Spencer Gregory Hale

 

Sr. Regulatory Affairs Specialist – Endoscopy

 

About the role:
Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work.  In the Endoscopy division, we provide advanced technologies for diagnosing and treating diseases of the digestive system, airway, and lungs.  Our robust product portfolio provides a variety of solutions including but not limited to balloon dilation, stenting, ERCP/cholangioscopy, biliary, biopsy and polypectomy, hemostasis, radio frequency ablation, and enteral feeding.  We continue to innovate and make investments in Endoscopy treatments, both within established product lines as well as in future pipelines.

 

The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.

 

Your responsibilities will include:

  • Act as company representative under minimal supervision, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, and submission review
  • Research, develop, and implement regulatory strategies for new and modified medical devices
  • Represent Regulatory Affairs on development core teams, providing Regulatory feedback and guidance throughout the product development cycle
  • Prepare and submit regulatory documentation and applications
  • Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes
  • Review and approve product and manufacturing changes for compliance with regulatory requirements
  • Support and maintain Quality initiatives in accordance with BSC Quality Policy
  • Continuously assess ways to improve Quality

 

Required qualifications:

  • A minimum of a bachelor’s degree in a scientific, technical, or related discipline
  • A minimum of 5 years’ Regulatory Affairs, or related experience (Quality, Clinical, R&D, Biocompatibility, etc.), within the medical device, pharmaceutical, or health care industry
  • Working knowledge of US, EU, and/or international regulations for medical devices
  • General understanding of product development process and design control

 

Preferred qualifications:

  • General understanding of regulations applicable to the conduct of clinical trial
  • Ability to manage several projects of moderate scope and complexity simultaneously
  • Proficiency with Microsoft Office
  • Effective research, analytical, and problem-solving skills
  • Effective written and oral communication, technical writing, and editing skills
  • Ability to work independently with minimal supervision

 

 Requisition ID: 582426

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.  

  • Sr. Regulatory Affairs Specialist

    2 weeks ago

    Marlborough, United States Knewin Full time

    Recruiter: Spencer Gregory Hale Sr. Regulatory Affairs Specialist – Endoscopy About the role: Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advanced technologies for diagnosing and treating diseases of the digestive system, airway, and lungs. Our robust...

  • Sr. Regulatory Affairs Specialist

    3 weeks ago

    Marlborough, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Sr. Regulatory Affairs Specialist - Endoscopy About the role: Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advanced technologies for diagnosing and treating diseases of the digestive system, airway, and lungs. Our robust...

  • Sr. Regulatory Affairs Specialist

    2 weeks ago

    Marlborough, MA, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Sr. Regulatory Affairs Specialist - Endoscopy About the role: Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advanced technologies for diagnosing and treating diseases of the digestive system, airway, and lungs. Our robust...

  • Principal Regulatory Affairs Specialist

    7 days ago

    Marlborough, United States Boston Scientific Full time

    Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S 4 HANA. Magellans goal is to simplify, standardize and modernize our core business processes, enabling BSC to better leverage the power of d Regulatory Affairs, Regulatory, Specialist, Product Owner, Principal, Business, Manufacturing, Business...

  • Principal Regulatory Affairs Specialist

    1 week ago

    Marlborough, United States Boston Scientific Corporation Full time

    **Work mode**:Hybrid**Onsite Location(s)**:Marlborough, MA, US, 01752**Recruiter**: Spencer Gregory Hale**Principal Regulatory Affairs Specialist** **About the role**: - Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S4 HANA. Magellan’s goal is to simplify, standardize and modernize our core...

  • Principal Regulatory Affairs Specialist

    5 days ago

    Marlborough, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role: Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S4 HANA. Magellan’s goal is to simplify, standardize and modernize our core business processes, enabling BSC to better leverage the power of data and to position...

  • Principal Regulatory Affairs Specialist

    1 week ago

    Marlborough, Massachusetts, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role: Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S4 HANA. Magellan's goal is to simplify, standardize and modernize our core business processes, enabling BSC to better leverage the power of data and to position...

  • Principal Regulatory Affairs Specialist

    4 days ago

    Marlborough, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role: Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S4 HANA. Magellan's goal is to simplify, standardize and modernize our core business processes, enabling BSC to better leverage the power of data and to position...

  • Principal Regulatory Affairs Specialist

    1 week ago

    Marlborough, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale   Principal Regulatory Affairs Specialist     About the role:   Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S4 HANA. Magellan’s goal is to simplify, standardize and modernize our core business processes, enabling BSC to better leverage the power of data...

  • Document Specialist

    4 weeks ago

    Marlborough, United States Talent Groups Full time

    Develop, produce, and maintain technical and user documentation. - Plan and execute writing projects with attention to complex technical content. - Present content effectively and report progress in meeting schedule milestones. - Utilize word processing tools proficiently. **Qualifications**: - Ability to determine project requirements and perform complex...

  • SR. Operations Project Specialist

    6 days ago

    Marlborough, United States BJ's Wholesale Club Full time

    Join our team of more than 34,000 team members, supporting our members and communities in our Club Support Center, 235+ clubs and eight distribution centers. BJ’s Wholesale Club offers a collaborative and inclusive environment where all team members can learn, grow and be their authentic selves. Together, we’re committed to providing outstanding service...

  • Sr. Manager, Medicaid Contract Administration

    6 days ago

    Marlborough, United States Sunovion Full time

    Title: Sr. Manager, Medicaid Contract Administration Location: Remote/occasional onsite (if local to MA). Flexible work/life balance. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell &...

  • Sr. Specialist, Quality Assurance, CSV

    5 days ago

    Marlborough, United States Moderna Theraputics Full time

    The Role In this role, this candidate will be responsible for cGMP compliance of computer system validation of process, facility, utilities, equipment, method and will be accountable for their execution in Moderna's Individualized Neoantigen Therapy program. Here's What You'll Do * Review and audit computerized system validation deliverables according to...

  • Senior Contract Specialist

    2 weeks ago

    Marlborough, United States Babcock Power Full time

    Babcock Power is an Equal Opportunity Employer (M/F/D/V). Start Over with Job Search Returning Applicant? Login Now Senior Contract Specialist Company:Babcock Power Services Location:Marlborough, MA Job Type:Legal Position Summary: Join a talented team of engineering professionals at Babcock Power. Babcock Power is the leading supplier of technology,...

  • Sr. Specialist, Quality Assurance, CSV

    5 days ago

    Marlborough, United States Moderna, Inc. Full time

    The RoleIn this role, this candidate will be responsible for cGMP compliance of computer system validation of process, facility, utilities, equipment, method and will be accountable for their execution in Moderna's Individualized Neoantigen Therapy program.Here's What You'll DoReview and audit computerized system validation deliverables according to 21 CFR...

  • Sr. Specialist, Quality Assurance, CSV

    6 days ago

    Marlborough, United States Moderna Full time

    The Role In this role, this candidate will be responsible for cGMP compliance of computer system validation of process, facility, utilities, equipment, method and will be accountable for their execution in Moderna's Individualized Neoantigen Therapy program. Here's What You'll Do Review and audit computerized system validation deliverables according to 21...

  • Senior Director Medical Affairs

    4 weeks ago

    Marlborough, United States Boston Scientific Full time

    Locations: Marlborough, MA | Arden Hills, MNWork Model: HybridAbout the role:This position is responsible for providing medical expertise, support, and guidance to the Endoscopy Division in the areas of quality and safety for all endoscopy products marketed worldwide and for all phases of clinical study of endoscopic devices. This role reports directly to...

  • Senior Director Medical Affairs

    1 month ago

    Marlborough, United States Boston Scientific Full time

    Locations: Marlborough, MA | Arden Hills, MNWork Model: HybridAbout the role:This position is responsible for providing medical expertise, support, and guidance to the Endoscopy Division in the areas of quality and safety for all endoscopy products marketed worldwide and for all phases of clinical study of endoscopic devices. This role reports directly to...

  • Senior Contract Specialist

    1 month ago

    Marlborough, United States Babcock Power Full time

    Position Summary: Join a talented team of engineering professionals at Babcock Power. Babcock Power is the leading supplier of technology, equipment and engineering services, to the power generation industry. We are an industry leader with both domestic and international customers. Under the supervision and direction of the Business Unit General Counsel, the...

  • Sr. Product Manager

    4 weeks ago

    Marlborough, United States Candela Full time

    **Sr. Product Manager (Upstream - Growth Segment)** Requisition Number **2729** Location **US - Marlborough, MA** State/Territory **Massachusetts** **Company Overview:** Candela Corporation is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. We are the market leader in the development,...