Regulatory & Clinical Affairs Specialist job Marlborough Massachusetts
Regulatory & Clinical Affairs Specialist job Marlborough Massachusetts
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Regulatory & Clinical Affairs Specialist Job



Employer Name: SpiderID: 8502364
Location: Marlborough, Massachusetts Date Posted: 3/21/2019
Wage: Negotiable Category: Wholesale
Job Code: R0001364

Job Description:

Make an impact with outstanding products from world-class brands including our 7 leadership brands: OXO®, Hydro Flask®, Vicks®, Braun®, Honeywell®, PUR®, Hot Tools®.

We have an immediate opening for a Regulatory & Clinical Affairs Specialist based out of our Marlborough, MA location.

What contribution will I make to Helen of Troy?

As a Regulatory & Clinical Affairs Specialist, you will support the Europe, Middle East and Africa (EMEA) Regulatory Manager, as well as the Regulatory and Clinical Functions in the US for updates, according to the new Medical Device Reporting (MDR) regulation. You will also ensure that all documentation is managed in accordance with quality system requirements for the US Food and Drug Administration (FDA), International Standards Organization (ISO), and international requirements in addition to performing supportive roles to clinical and regulatory affairs.

What will I be doing?

  • Support EMEA activities for conversion from Medical Device Directive (MDD) to Medical Disaster Response (MDR).
  • Support VP of Regulatory and Clinical Affairs for special projects and support any publications as necessary.
  • Support of Quality Management System documentation to ensure compliance to the Code of Federal Regulations (CFR) and International Standards Organization (ISO) (Standard Operating Procedures, Work Instructions, etc.).
  • As required, support engineering / program management / marketing teams from a documentation perspective.
  • Provide support to internal customers to ensure compliance with US, Latin America, Canadian, European, African, and Asia Pacific government requirements with regards to commercial and post-marketing activities.
  • Support clinical programs, as necessary, including, writing clinical protocols, clinical reports, clinical study management documents, clinical trial agreements, and acquisition and management of clinical data, with oversight from the Director of Clinical & Regulatory Affairs.
  • Perform validation of electronic Case Report Forms (CRFs) and Trial Master Folders (TMFs).
  • Support the Management Review process of global suppliers by being the administrator for the quarterly meetings.
  • Maintain the global Approved Vendor List (AVL).
  • With the internal auditor, coordinate the timing of internal audits and manage their occurrence.
  • Assist with documentation related to internal audits and bringing closure to internal audit findings.
  • Assist with external audit preparation, documentation retrieval related to external audits and with bringing closure to external audit findings.
  • Review Engineering Change Orders (ECO’s) for non-medical devices.
  • Review and implement Document Change Orders (DCO’s) for Quality Management System documents.
  • Uphold and foster best practices related to Quality System (21CFR and ISO 13485).
  • Initiate and assist with maintaining Standard Operating Procedures (SOP’s) and keeping them current/updating as required.
  • Managing the periodic review process.
  • Assist with regulatory submissions as required, with oversight from the Director or VP of Regulatory /Clinical Affairs.

What are the requirements for consideration?

  • Bachelor’s Degree or other 4-year Degree from an accredited college or university in a relevant field.
  • 1+ years’ experience in clinical and / or regulatory affairs in medical devices with documentation experience.
  • Detail-oriented finisher, quick-learner, personable, ability to handle diversity and work with our team and suppliers in US, Europe, and other locations.
  • Rudimentary knowledge of Quality System Regulations and Medical device GMP’s is a plus.
  • Ability to work well with data, documents, and people.
  • Must be organized, able to handle multiple projects at once, and remain flexible and adaptable in a fast-paced environment.  
  • Ability to build strong working relationships across a multi-functional organization is critical with a high level of professionalism.
  • Ability to communicate and work with internal stakeholders and external agencies.
  • Results orientation, sense of urgency, sound judgment, and attention to detail.
  • Must be flexible and able to effectively manage multiple competing priorities for multiple customers.
  • Proficient PC skills (e.g. MS Office, Adobe, Oracle, Business Objects, FileMaker).
  • Applicants must be eligible to work full-time in the United States.

To learn more about Helen of Troy, visit us at www.helenoftroy.com

You can also find us on LinkedIn, Glassdoor, Facebook, and Twitter.

Helen of Troy is an Equal Opportunity / Affirmative Action Employer

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status. 

If you, as one of our employees or as an applicant for employment, have any questions about our Affirmative Action Plan, please contact Human Resources during regular business hours. 

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Human Resources at (915) 225-8000.



Job Criteria:
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: Helen of Troy Company Type:
Company: Helen of Troy
City:
State:
Zip:

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