
Senior Regulatory Affairs Expert
9 hours ago
Regulatory Affairs Specialist Opportunity
A leading global medical technology company seeks a seasoned Regulatory Affairs specialist to drive their regulatory vision and strategy.
About the Role
We are looking for a highly experienced Regulatory Affairs professional to lead our regulatory team, develop strategic plans, and ensure compliance with regulatory standards.
- Key Responsibilities:
- Develop and drive regulatory strategies to align with business goals, focusing on product development, marketing, and post-market surveillance.
- Build and lead a high-performing regulatory team, fostering a culture of excellence, innovation, and accountability.
- Provide guidance on risk management and compliance to senior leadership, ensuring timely regulatory submissions and approvals.
- Advocate for streamlined regulatory pathways by engaging with regulators and industry groups.
- Oversee regulatory responses to audits, inspections, and post-market surveillance requirements, ensuring adherence to ISO 13485 and knowledge of SaMD products.
- Partner with cross-functional teams to integrate regulatory requirements, provide regular updates, and input to ensure compliance with applicable standards.
Requirements
The ideal candidate will have:
- Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related fields.
- Minimum 10-15 years of regulatory experience, with at least 5 years in a leadership role.
- In-depth understanding of India's Medical Devices Rules, 2017, CDSCO guidelines, and applicable standards.
- Familiarity with global regulations like FDA (21 CFR), EU MDR/IVDR, and other regional requirements for international market access.
- Proven track record of managing regulatory strategies for medical device companies.
- Exceptional leadership, communication, and negotiation skills.
- Strategic thinker with a proactive approach to problem-solving.
What We Offer
As a key member of our team, you will receive:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
-
Senior Regulatory Affairs Specialist
5 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,73,37,000 - ₹ 2,53,53,000Regulatory Affairs ExpertWe are seeking a highly skilled Regulatory Affairs expert to join our team. As a key member, you will be responsible for driving regulatory intelligence and surveillance initiatives that impact millions of patients worldwide.Key ResponsibilitiesConduct regulatory monitoring, identify key requirements, and maintain awareness of global...
-
Regulatory Affairs Expert
7 days ago
Bengaluru, Karnataka, India beBeeExcellence Full time ₹ 90,00,000 - ₹ 1,20,00,000Unlock Regulatory ExcellenceJob Description:As a Regulatory Affairs Specialist, you will play a vital role in ensuring the compliance of our solutions in Healthcare, Life Science, and Electronics. You will work closely with cross-functional teams to define regional regulatory strategies for product changes and serve as an internal point of contact for TA and...
-
Bioequivalence Regulatory Affairs Expert
1 day ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 25,00,000 - ₹ 40,00,000Job OpportunityWe are seeking a skilled Regulatory Affairs Professional to manage regulatory activities for biosimilar products in the emerging LATAM market.This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations.Main Responsibilities:Develop and...
-
Senior Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full timeRegulatory Affairs ManagerWe are seeking an experienced Regulatory Affairs Manager to oversee and execute all regulatory activities for drug substances and products.
-
Senior Regulatory Affairs Publishing Manager
1 week ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,75,00,000 - ₹ 2,50,00,000Regulatory Affairs Professional Job DescriptionOur team seeks a skilled Regulatory Affairs Associate Senior to lead the publishing and dispatch of regulatory submissions for Devices & Drugs Submissions. Key responsibilities include:Managing and leading regulatory publishing operations globally.Ensuring submissions meet eCTD requirements and other regional...
-
Regulatory Affairs Expert
7 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,00,00,000As a Regulatory Affairs Specialist, you will play a critical role in ensuring our products meet local and international standards. We seek a detail-oriented and proactive professional to support strategies, submissions, and compliance activities across global markets.Key Responsibilities:Regulatory Submissions & Approvals:Prepare, review, and submit...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000Regulatory Affairs SpecialistThis role is a great opportunity for individuals with a strong understanding of regulatory affairs and a passion for ensuring compliance. The Regulatory Affairs Specialist will play a critical role in assisting international regulatory teams with navigating evolving business needs in the Indian market.Key...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to manage and support regulatory submissions, ensure compliance with global regulatory requirements, and maintain the highest standards of operational excellence in regulatory processes.">Technical skills: Deep...
-
Regulatory Affairs Professional
2 weeks ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 8,46,992 - ₹ 12,99,898Regulatory Affairs AssociateThis is a critical role that involves providing regulatory support to various departments across the organization. The successful candidate will be responsible for ensuring that all regulatory activities align with business needs.Key Responsibilities:The Regulatory Affairs Associate will be responsible for:Providing regulatory...
-
Senior Regulatory Affairs Expert
6 hours ago
Bengaluru, Karnataka, India beBeeExpert Full time ₹ 1,20,00,000 - ₹ 2,50,00,000Regulatory Affairs SpecialistWe are seeking a skilled professional to lead our regulatory efforts. In this role, you will be responsible for developing and implementing regulatory strategies to support product development.Key Responsibilities:Plan and manage the development of high-quality regulatory documents, including briefing documents, CTAs, IND/IMPD,...