Overview
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible.We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams.We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.At QIAGEN, every day is an opportunity to make a real-life impact.Join us, grow with us, and together, let's shape the future of biological discovery.
Position Description
QIAGEN seeks an experienced and motivated Regulatory Affairs Manager to lead and undertake regulatory responsibility for India (direct market) and South Asia (i.e. Bangladesh, Pakistan, Sri Lanka, Nepal, Bhutan). The role ensures IVD products comply with regional regulations and laws for market access, including obtaining product registrations/approvals and supporting commercial partners. The RA Manager will provide strategic guidance to internal and external stakeholders, ensuring regulatory compliance for import, registration, and commercialization and lifecycle management of medical devices and diagnostics. The position will report to Sr Manager Regulatory Affairs (AU/NZ) within the QIAGEN RA Rest of World Team.
Position Requirements
- Prepare, submit, and maintain country-specific registration files (new applications, renewals, changes) for India and South Asia, reporting to regional and global management.
- Establish and maintain robust reporting mechanisms for registration status and regulatory intelligence, ensuring timely updates to local and global management.
- Research, interpret, and monitor local regulations, guidelines, and precedents; identify regulatory risks and propose mitigation strategies.
- Serve as primary interface with regulatory agencies in India and commercial partners for South Asia, representing QIAGEN in all regulatory matters.
- Assess clinical protocols, R&D protocols, labelling, and marketing materials for regulatory compliance and impact.
- Collaborate with commercial partners, distributors, and contract personnel to support local registration needs and activities across South Asia.
- Provide regulatory support to Global RA, R&D, Production, Marketing, and Sales, coordinating with local/regional functions to achieve company objectives.
- Develop, maintain, and ensure compliance with SOPs relevant to IVD product registration and other regulatory activities.
- Support due diligence and regulatory assessments for new business opportunities and partnerships in the region.
- Monitor and communicate changes in regulatory requirements, proactively updating internal stakeholders and adapting strategies as needed.
- Train and mentor internal teams and commercial partners on regulatory requirements and best practices.
Digital Submissions & e-Governance
- Utilize CDSCO’s SUGAM portal and Medical Device Portal for digital submissions, tracking, and compliance documentation.
- Ensure timely and accurate electronic submissions, including auto-generated compliance certificates and export codes.
- Maintain familiarity with digital tools and evolving e-Governance initiatives to streamline regulatory workflows.
Post-Market Surveillance (PMS)
- Implement and manage PMS systems in accordance with CDSCO and WHO guidance.
- Collect and analyze user feedback, adverse event reports, and performance data.
- Conduct root cause analysis and initiate corrective and preventive actions (CAPA).
- Coordinate Field Safety Corrective Actions (FSCA) and communicate Field Safety Notices (FSN) as required.
- Ensure compliance with recall procedures and reporting timelines.
Current Regulatory Trends
- Stay abreast of India’s evolving risk-based regulatory framework under MDR 2017.
- Align with international standards (IMDRF, ISO 13485, WHO PMS guidance).
- Monitor developments such as the Uniform Code for Marketing Practices in Medical Devices (UCMPMD).
- Support in-country performance evaluations for Class B–D IVDs
Education
Personal Requirements
- Minimum Bachelor’s Degree in a scientific discipline (life sciences, pharmacy, biomedical engineering, etc.)
Experience
- Minimum 5+ years’ experience in Regulatory Affairs, preferably with RAC certification.
- At least 3 years’ direct experience with medical device/IVD regulations in India; experience in South Asian markets (Bangladesh, Pakistan, Sri Lanka, Nepal, Bhutan) highly desirable.
- Demonstrated success in managing regulatory submissions and interactions with regulatory authorities in India and South Asia.
- Experience working with commercial partners/distributors on regulatory matters.
- Strong leadership and project management skills; ability to work independently and make sound regulatory decisions.
- Strong leadership skills with supervisory/management experience and demonstrated ability to interact professionally with governmental agencies and peers
- Excellent organizational, written, and oral communication skills in English; proficiency in local languages is an advantage
Interpersonal Skills
- Strong interpersonal and communication skills; able to interact effectively with internal teams, regulatory authorities, consultants, and commercial partners.
- Ability to influence and negotiate with external stakeholders, including government agencies and business partners. .
Supervisory Responsibilities
- May supervise contract personnel or coordinate with external consultants; does not directly supervise employees.
Travel
Minimal to moderate travel required (up to 25%), including travel within India and to South Asian countries as needed. Visits to Regulatory Authorities.
What We Offer
- Bonus/Commission
- Local benefits
- Referral Program
- Volunteer Day
- Internal Academy (QIALearn)
- Employee Assistance Program and internal QIAGEN communities
Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.
QIAGEN is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.
