Share this Job
Apply now »

Associate Director, Global Regulatory Affairs, Medical Devices

This role has flexibility to be based in Rockland, MA or Billerica, MA.

Your Role:

Responsible for developing and leading Global regulatory strategies for submissions and approvals of clinical trials and original marketing applications for products within the EMD Serono combination product and device portfolios.

  • Provide regulatory strategy for assigned products within the EMD Serono device portfolio
  • Support organizational readiness for MDR implementation
  • Identify and execute on opportunities to build a relationship of trust, scientific credibility, and partnership with relevant internal and external stakeholders (such as health authorities) leading to early engagement to accelerate development
  • Work effectively in the broader matrixed organization to deliver an aligned and successful regulatory strategy
  • Ensure compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities

 

Who you are:

Required:

  • Bachelor’s Degree in scientific or life sciences discipline or related required.
  • 5+ years in device regulatory affairs
  • Proven track record of effective collaboration with the regulatory authorities, demonstrated ability to act as a credible, influential, respected spokesperson during interactions
  • Ability to negotiate within a highly matrixed environment to deliver complex messages and facilitate appropriate team decisions, insightful and forward thinking, ability to recognize, anticipate and proactively manage regulatory needs
  • Skilled in presenting management with recommendations that reflect full consideration of available options and a strong business judgement on balance of risk
  • Communicate with clarity, impact, and passion tailored to the audience

Preferred:

  • Advanced degree in scientific or life sciences discipline or related (PharmD, PhD, MD) strongly preferred.
  • Actively engages colleagues, interacting broadly with other members of GRA
  • Demonstrated track record of success contributing in a globally oriented environment

 

Job Requisition ID:  194771
Location:  Billerica
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Boston

Job Segment: Medical, Manager, Medical Device, Healthcare, Management

Apply now »