Danaher Corporation Quality Assurance and Regulatory Affairs Analyst in New Delhi, India
Key responsibilities and accountabilities:
Ownership of due diligence process for new and for existing CP
Manages a screening process for distributors and plans, gathers information and documents from CP’s required for due diligence process
Invite CP to complete the online Securimate application and review the application submitted by CP for completeness and co-ordinate with CP for missing documents
Establish and manage the due diligence/compliance process for the BCIPL
Ownership of the distributor network scorecard process
CP agreement review and participation in negotiation phase when appropriate
Organizes compliance and anti-corruption trainings for channel partners and tracks completion of all mandatory trainings on yearly basis
Establish and manage the CP compliance process for the entity
Communicates compliance activities to Commercial and Senior Management,
Establish a process for monitoring the expiry date of the drug licenses of our channel partners and ensure other compliances related to DL
Support and manage the life cycles of CP (selection, managing performance, exit and transition)
Requires degree in a science / Pharmacy or related field.
At least 8- 10 years of relevant experience within the CP management process in medical devices or IVD industry.
In depth knowledge of Indian and other jurisdiction regulatory requirements.
Experience in working in a matrix organization, international environment and experience in managing people.
Very good analytical and problem-solving skills as well as interpersonal skills with emphasis on diplomacy, negotiation and ability to work in a team-based setting; effective communication skills; flexibility; self-confidence, achievement-oriented with appropriate concern for quality are highly desirable qualifications.
Paying attention to details.
Adaptability to work under time pressure & able to independently work within a team
Strong interest for Customer Satisfaction
IT literate with MS Office.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.