Regulatory Affairs Specialist

Regulatory Affairs, FDA, 510(k), 510 (k)
Full Time, Full Time / Perm
$90-100K + Bonus
Telecommuting not available Travel not required

Job Description

Please note I have direct access to the Hiring Regulatory Affairs Manager on this position.

The leading Global Biotech Company in its niche is looking for a Sr. Regulatory Affairs Specialist. The company has been in business for 50+ years, is publicly traded, has 7+K employees, has $5.2B in revenues (14% increase over FY 2017), $108 million in profits (42% increase over FY 2017), has 750 product patents, released 4 new products in 2017 and is an active philanthropic institution.

The Sr. Regulatory Submissions Affairs Specialist will be responsible supporting and managing a medical device manufacturer regulated by the FDA in the United States and similar bodies in other countries (Asia, South America, Canada). The Sr. Regulatory Affairs Specialist will ensure that the company complies with the United States’ Federal Code of Regulations for medical devices, the Mexican Ministry of Health requirements and Health Canada's Canadian Medical Devices Conformity Assessment System (CMDCAS) and CE Mark products. The Sr. Regulatory Affairs Specialist will:

  • Prepare and file 510(k) based on technical information provided by the project development team.
  • Follow the 510(k) through to completion by tracking its review progress at the FDA and coordinate any responses to FDA requests for further information.
  • Gather requirements and perform assessments for global launches
  • Review Engineering Change Control Requests and determine global impact

The Regulatory Submissions Specialists report to the Regulatory Affairs Manager

Company offers a comprehensive benefits package including: medical, dental, and vision coverage for employees; vacation and paid company holidays; 6% matching 401K; 6% pension contribution, flexible spending plans, tuition reimbursement and a casual work environment.

REQUIREMENTS:

Must have 5+ years’ experience determining regulatory requirements and status for new/proposed medical devices, pharmaceuticals and/or biotech products

Experience preparing submissions for 501(k)

Experience interacting with the FDA and be familiar with FDA regulations, guidelines and requirements

 

The following are only a Plus (NOT mandatory):

 

Any experience preparing submissions for CE Mark products, IDE’s, IND’s, NDA’s and ANDA’s

Compliance with United States’ Federal Code of Regulations for medical devices, European Economic Community: Council Directive and Health Canada: Medical Devices Regulations

Any experience with medical device regulations such as: 21 CFR 820, ISO 13485, ISO 62304, ISO 60601-1

Any experience or knowledge of pharmaceutical and/or biologic regulations and standards would be a plus

BS/MS and/or Regulatory Affairs Certification

Posted By

Al Karaptian

Hermosa Beach, CA, 90254

Dice Id : equest
Position Id : 601
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