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Job Details

Regulatory Affairs Manager (Medical Devices & Software)

Company: RBW Consulting
Location: Waltham, MA
Reference: RAA-RAMMDS-WMA
Closing Date: 10 Dec 17
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Regulatory Affairs Manager (Medical Devices & Software)

Waltham, MA

Technical Competencies:

  • Knowledge of the medical device Regulatory Affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, etc.
  • Knowledge of US laws, regulations, and guidances that affect assigned devices
  • Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
  • Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate to product development and labeling regulatory activities for assigned devices
  • Ability to influence and partner with cross-functional teams
  • Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
  • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks

Professional Competencies:

  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Strong capability to contribute and lead in a team environment
  • Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
  • Excellent communication skills; both oral and written
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner through technical excellence and mutual respect
  • Demonstrated ability to contribute to a continuous learning and process improvement environment
  • Capacity to react quickly and decisively in unexpected, fluid situations
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
  • Focused ability to influence operational excellence and performance metrics
  • A risk averse nature when needed, with the ability to identify potential solutions to complex problems

EXPERIENCE AND REQUIRED SKILLS:

  • 6 – 8 years’ related experience.
  • 3+ years’ supervisory or project/program management experience preferred. Experience should include effective interaction with manufacturing, quality, clinical/medical and marketing departments.
  • Prior 510(k) experience required.
  • Experience with international regulations preferred.
  • Demonstrated working knowledge of scientific principles.
  • Demonstrated ability to work effectively in a highly charged, fluid environment.
  • Demonstrated ability to independently manage multiple projects.
  • A self-starter with the ability to work as a Project Leader managing projects and allocation of resources to those projects.
  • Very detail-oriented, well-organized, and driven to meet deadlines and program goals.
  • Strong verbal and written communication skills, including the ability to make effective and persuasive presentations.
  • Good computer skills with knowledge of Microsoft Office.

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Regulatory Affairs Manager (Medical Devices & Software)

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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