Director Regulatory Affairs – MA

Catalyst

Director Regulatory Affairs – MA


  Nashua, New Hampshire
Posted
3 weeks ago
Duration
Permanent
Salary
$180,000 - $220,000
Sector
Regulatory Affairs

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Opportunity to join one of the world's most recognizable Medical Device organizations as part of their spin-off company dedicated to the mission of providing treatment for a disease that affects over 40 million of the US population. Leading the overall regulatory strategy and development for the company's flagship product, managing two specialized individuals, this is a chance to join a start up environment with the financial backing of a global medical devices behemoth.

Responsibilities

  • Leading the regulatory department Directing the preparation of submissions (Pre-Meetings, PreSubs, 510(k)s)).
  • Providing leadership to the team, and sit in on executive meetings to relay the regulatory strategy and progress on the product for US submission 
  • Identifying and communicating risks and mitigations associated with regulatory strategies to cross-functional partners.
  • Developing associated strategies and tactical plans for submissions to FDA, EU Notified Body and other agencies.
  • Representing the company and regulatory department in interactions/negotiations with U.S. and global regulatory agencies

Experience & Education

  • Minimum 10 years of directly related professional regulatory experience within the medical devices industry,
  • Experience working within large organizations, understanding the structure of a global medical device corporation
  • Previous experience leading a regulatory affairs department to successful submissions. 
  • B.S. or B.A. degree in a technical subject area (e.g., engineering, biology, chemistry). 
  • Experience leading meetings and negotiating with FDA personnel in the device (CDRH) areas and other global Health Authorities.
  • Proven success in the strategy development, preparation, and authoring of regulatory submissions (PreSub, 510(k)) and correspondences to FDA.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Callum.Sparkes

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Contact

Callum Sparkes

Email Callum
1 857 233 9328
 

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