What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at Redbock - an NES Fircroft company?
A leading Medical Device company in Marlborough, Massachusetts is in need of a Senior Regulatory Affairs Specialist to work with them for 6 months. This is a hybrid on-site position 3 days onsite, 2 days remote. Target start date is 4/21.
The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include 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.
- Responsibilities:MDR Sustaining support related to PSUR, SSCP, and/or Sampling Plan submissions. This is inclusive of the following activities:
- Leading Core Team meetings to collaborate cross-functionally on PSUR, SSCP, and Sampling Plan submissions
- Approving change notices for documentation updates required to submit to Notified Bodies
- Prepping and submitting documentation submission package to Notified Body
- Act as primary contact to Notified Body for any product submission questions
- Reviews and collaborates with design, clinical, and manufacturing teams on responses to questions from EU regulatory bodies related to compliance to the EU Medical Device RegulationRegula
tory Sustaining product support. This is inclusive of the following activities:Active
- engagement in product / project team meetingsReview
- , recommend appropriate changes, and approve product change noticesPrepar
- e and submit regulatory documentation and applications, as applicableReview
- device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changesReview
- and approve product and manufacturing changes for compliance with regulatory requirementsDesign
- History File documentation creation, updates, and approval within the documentation management systemSuppor
t and maintain Quality initiatives in accordance with Quality PolicyContin
uously assess ways to improve Quality Basic
- qualifications:Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline5 years Regulatory Affairs experience, medical device industry experience requiredWorking knowledge of FDA and international regulations for medical devicesGeneral understanding of product development process and design controlGeneral understanding of regulations applicable to the conduct of clinical trialsPreferred qualifications:Ability to manage several projects of moderate scope and complexityProficiency with Microsoft OfficeEffective research, analytical, and problem-solving skillsEffective written and oral communication, technical writing, and editing skillsAbility to work independently with minimal supervision
