Senior Lead, Regulatory Affairs

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.

• Compilation of Medical Device Dossier w.r.t Indian regulatory requirements for Registration, Clinical Trial Permissions, License Transfers, Import License, New Product Approvals, Renewals
• Regular follow-ups with CDSCO
• Work with other regulatory authorities like Atomic Energy Review Board (AERB), Department of Telecommunication (DoT), Legal Metrology, etc.
• Framework: Medical Write-ups and Executive summaries
• Addressing Technical Queries both from regulators and internal stakeholders
• Change Management including tracking and submission of product/ site changes
• Acquisition related submissions, project planners and follow-ups
• Preparation of Technical literature/ presentation(s) w.r.t. Subject Expert Committee meetings
• Communicate new local requirement/ new product registration / update in labelling information/ update in MRP to labelling team and ensure correctness in label release.
• Application for new warehouse license or amendment in the existing warehouse license
• Applies understanding of business acumen and stakeholder management to accomplish the project
• Demonstrates knowledge of the company, processes and customers
• Uses prescribed guidelines or policies in analyzing situations and resolving problems to deliver continuous business results
• Provide informal guidance to team members
• Regulatory Compliance Management:
• Mapping imports with existing approvals
• Mapping current practices with existing regulations

• Graduate/Postgraduate in any life sciences/Engineering
• 8 years of relevant experience

Location: Gurugram, India
Requisition ID: 588066

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isnt just business, its personal. And if youre a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Companys policies or protocols change with regard to COVID-19 vaccination.

Locations: Gurgaon, IN