Associate Director, Medical Devices & Combination Products - Gaithersburg, MD | Biospace
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Associate Director, Medical Devices & Combination Products

AstraZeneca Pharmaceuticals LP

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Macclesfield,
United Kingdom
United States
Västra Götaland,
Job reference: R-010992

Posted date: Jul. 19, 2017

We lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has big impact on science and medicine.

The Regulatory Affairs CMC (Chemistry, Manufacturing & Control) group sits within the AZ Global Regulatory Affairs, Patient Safety and Quality Assurance (GRAPSQA) organisation and is accountable for delivering CMC regulatory strategy as well as operational and tactical expertise for projects throughout the product lifecycle.

We are now looking for an experienced Associate Director (AD) to join our Regulatory CMC team in either Macclesfield, Gaithersburg or Gothenburg. As AD you will be responsible for providing device related regulatory expertise, guidance and input to medical device and combination product projects. These systems may incorporate electronic and software technology. This position will require significant interaction within research and development functions particularly working with the Device Technical teams in Pharmaceutical Technology & Development, as well as collaborating with AstraZeneca’s manufacturing and quality organizations. This individual must be able to effectively work in a matrix environment and drive consensus on 'best answer' for complex scientific and product initiatives. Key accountabilities will include;-

  • Advising product development teams on device related regulatory aspects of medical device & combination product projects including (but not limited to) those involving inhalation devices and companion software-based devices
  • Reviewing and contribute to medical device & combination product regulatory submissions and documentation (INDs, CTAs, BLAs, MAAs, 510(k)s, Technical Files etc…)
  • Supporting preparation for meetings with regulatory agencies and attend as required
  • Supporting the development and implementation of guidance and requirements for regulatory strategies for medical devices & combination products
  • Supporting development and integration of regulatory processes for medical device/combination product development and commercialisation interfaces
  • Advising on and support medical device/software/combination product regulatory compliance initiatives
  • Supporting the development and integration of connected delivery devices and app/software-based companion platforms
  • Supporting AZ device related networks
  • Supporting and coach peers within AZ
  • Representing AZ at external events (PhRMA, PDA, ISPE, BIO, DIA, IPAC-RS, AAMI/ISO, etc.), as required

Minimum Requirements

  • BS/MS in a Regulatory Affairs, Life Sciences, Engineering or related field.
  • Proven experience in regulatory affairs with a focus on combination products and medical devices (including knowledge of electronic/software-based devices). Other relevant experience in the biopharmaceutical industry considered.
  • Significant experience in the combination product or medical device industry
  • Demonstrated experience in Regulatory Affairs [e.g. IDE/510(k)/PMA filings; application of device quality management system, software validation, human factors, and design verification/validation requirements]
  • International Regulatory Affairs experience e.g. CE marking, technical file/design dossiers, application of international device standards (eg, ISO 14971, ISO 13485, ISO 60601, IEC 62304) and medical device and/or combination product regulations
  • Strong understanding of regulations governing marketing of medical device & combination products

Please note applications must include your current CV and be submitted before midnight on Aug 31st 2017.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.


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