JOBS      

At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health.

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical Solutions and Medical Aesthetics is also what differentiates us — the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our increasingly global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together we advocate for better health and wellness through solutions that provide even-greater certainty and peace of mind.

Part-Time Regulatory Affairs Executive, ASEAN + South Asia

Location: Mumbai, Maharashtra IN

Apply

Job Number: 1025

External Description:

Hologic (HOLX) is a leading developer, manufacturer and supplier of diagnostic products, medical imaging systems, surgical products and medical aesthetics with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of cervical and breast cancer, improved diagnosis and less invasive treatments. 

Part-Time Regulatory Affairs Executive, ASEAN and South Asia (ASA)

The Position

The incumbent will have a direct reporting line to the Senior Manager, RAQA, ANZ, ASEAN and South Asia (ASA)

Summary

The caliber of the Regulatory Affairs (RA) Executive, ASA will have regulatory oversight responsibility for the region of ASEAN and South Asia.  The successful candidate will be responsible for product registrations, supporting sales and marketing and distributors. He/She will be responsible for all support activities relating to regulatory affairs activities in the region. 

Duties & responsibilities:

  • Facilitate communications and documentations between Business Units, distributors and regional head office
  • Manage product registration projects and coordinate with manufacturing sites for support and documentation
  • Ensure registration activities are completed on-time based on business priorities
  • Maintain registrations tracking register and prepare monthly reports
  • Coordinate and keep track of FSCAs
  • Support sales and marketing on tenders and operational issues

The Person

The successful candidate will have in-depth understanding of the ASA medical device or IVDs regulatory environment. He/She must be able to excel within a results-oriented environment where regulatory activities must be executed timely and accurately. The incumbent must possess strong communication skills, as well as medical device regulatory knowledge and a high degree of technical competency in life science or Engineering. He/She must also be creative, strategic, accountable and decisive.  

In addition, the successful candidate will possess:

  • Proven product registration success track record across multiple product lines
  • Good knowledge of current global (EU MDD, US FDA) and ASA regulatory requirements
  • The ability to demonstrate success with establishing and maintaining existing regulatory authority contacts and opening new communications with competent authorities
  • The ability to demonstrate strategic, conceptual, and analytical skills, including a solid understanding of relevant regulations and standards
  • Multi-national company experience with specific success working for US or European based companies

Qualifications / Education

  • An undergraduate degree in a Life Science or Engineering discipline is required
  • Postgraduate degree as well as regulatory proficiency based on certifications is highly desired
  • Minimum 3 year experience within the medical device or IVDs industry
  • Excellent communication skills with ability to effectively interact at all levels of a company

Working Environment and Other Entitlements:

  • 3 days a week work schedule
  • Remote working location i.e. work from home (if role is based in India or Malaysia)
  • This role is open candidates based in Mumbai, Singapore or Malaysia

 *** Incumbents who are seeking flexible work hours are welcomed to apply!

 

Job Number: 1025

Community / Marketing Title: Part-Time Regulatory Affairs Executive, ASEAN + South Asia

Location_formattedLocationLong: Mumbai, Maharashtra IN