Sr. Regulatory Affairs Specialist

Troy - Michigan - United States - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Bachelor

Develop regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.

Location: Irvine CA - open to remote -Must be US based

Feel free to contact

Sinead McLaughlin, Account manager

Apply now

About this role

  • Under moderate supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, responsible for the following Regulatory activities:
  • Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards;
  • Author regulatory submissions and assessments for class II and III medical devices to be distributed in the US to ensure timely global commercialization of products in compliance with applicable regulations and standards;
  • Author technical files and design dossiers for products to be distributed in the EU;
  • Prepare international documentation to support product registration internationally;
  • Directly communicate with FDA and other Regulatory agencies in preparing responses to submissions and in support of agency audits;
  • Evaluate proposed changes to product design or manufacturing processes and assess impact of the proposed changes with regard to worldwide approvals and internal BWI policies and procedures;
  • Participate on new product development teams;
  • Review and approve new product development and product modification documentation;
  • Write, review and revise company SOPs as required;
  • Communicate business related issues or opportunities to next management level;
  • Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
  • Perform other duties assigned as needed.

About you

  • BS degree in Engineering, Physical or Biological science + minimum of 4 years experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries, OR Advanced degree + 2 years experience in Regulatory Affairs or other related discipline;
  • Must be familiar with MS Office applications;
  • Excellent communication skills (verbal and written);
  • Project management skills;
  • Problem solving skills;
  • Presentation skills;
  • RAC Certification preferred.

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB214001
  • Location: Troy
  • Market: Life Sciences & Health Care
  • hours per week: 35
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Regulatory
  • Closing date: Monday, July 8, 2019
Apply now

Feel free to contact

SM

Sinead McLaughlin

Account manager Brunel Energy Canada Calgary

+1 403 539 5009

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