Regulatory Affairs Specialist
6 days ago
Job Title: Principal Regulatory Affairs Specialist
Job Description:
Key Responsibilities:
- Develop and execute regulatory strategies for new product development, design changes, and field safety corrections for US, EU, and RoW.
- Author 510k submissions, lead pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications, and lead interactions with regulators/competent authorities throughout the review and approval process.
- Participate in strategic product development, design solutions starting from the concept phase to product delivery phase, and provide regulatory guidance throughout design and development.
- Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to other RA Staff and project teams. Manage special projects across the spectrum of product lines.
- Monitor global regulatory landscapes and guide cross-functional teams on the implementation of regulation changes.
- Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with regulatory requirements.
- Support product defect assessments, issue impact assessments, health hazard evaluations, corrections, and removals, and CAPAs as a regulatory subject matter expert.
- Review labeling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements.
- Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms, and apply technical expertise to process improvement efforts. Lead or participate on process improvement teams to affect changes at a local or cross-business unit level.
- Opportunity for mentoring and coaching other regulatory team members and providing regulatory guidance.
Requirements:
- Minimum of 7-10 years of experience in the Regulatory Affairs medical device industry with regulatory submission experience; 510(k) experience is preferred.
- Preferred candidate will have a master's degree in engineering or regulatory affairs or a related field with a minimum of 7 years of experience. Will consider applicants with a Bachelor's Degree and demonstrated experience working within the Medical Device industry.
- Mastery in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations. Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentations, and global registrations.
- Strong written, oral, and interpersonal skills required to work in a team environment as well as individual contributor with minimal supervision.
- Solution and detail-oriented, well-organized, and self-motivated with the ability to negotiate with regulators.
- May require up to 20% travel.
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Parexel Full timeRegulatory Affairs SpecialistAt Parexel, we're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for managing the regulatory life cycle of drug products, from pre-approval to post-approval. Your expertise will be essential in ensuring compliance with regional regulatory...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India Biocon Full timeJob Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon. The successful candidate will be responsible for preparing, reviewing, and submitting ANDA/ANDS in the US market, including modules.Key Responsibilities:Hands-on experience in preparation, review, and submission of...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Baxter Full timeAbout VantiveVantive is a new company built on the legacy of Baxter, a leading healthcare company. We are on a mission to revolutionize kidney care and other vital organ support.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for supporting all regulatory activities...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Baxter Full timeTransforming Healthcare through Regulatory ExcellenceBaxter is a leading global healthcare company that has been pioneering medical innovations for over 85 years. Our mission is to save and sustain lives, and we're looking for talented individuals to join our team in Regulatory Affairs.As a Regulatory Affairs Specialist, you will play a critical role in...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Baxter Full timeTransforming Healthcare through Regulatory ExcellenceBaxter is a leading global healthcare company that has pioneered significant medical innovations for over 85 years. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance and quality of our products and therapies.Your key responsibilities will include:Creating and...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Baxter Full timeRegulatory Affairs SpecialistBaxter is a leading healthcare company that is on a journey to separate its ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve.We are seeking a highly skilled Regulatory Affairs...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Philips Full timeJob Title: Principal Regulatory Affairs SpecialistJob Summary:We are seeking a highly experienced Principal Regulatory Affairs Specialist to join our team at Philips. The successful candidate will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for US, EU, and...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India Philips Full timeJob Title: Principal Regulatory Affairs SpecialistJob Description:The Principal Regulatory Affairs Specialist will play a key role in developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for the US, EU, and RoW. This includes authoring 510k submissions, leading pre-sub meetings, creating...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Biocon Full timeJob Title: Formulation Regulatory AffairsAt Biocon, we are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring compliance with regulatory requirements for our formulation products in the US market.Key Responsibilities:Prepare, review, and submit ANDA/ANDS filings in the US...
-
Regulatory Affairs Specialist
6 days ago
Bengaluru, Karnataka, India Baxter Full timeTransforming Healthcare through Regulatory ExcellenceBaxter is a leading medical innovation company that has been pioneering significant medical breakthroughs for over 85 years. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance and quality of our products and therapies.Key Responsibilities:Create and review...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India Parexel Full timeJoin Parexel's Team of Regulatory Affairs ExpertsJob Description:As a Senior Regulatory Affairs Associate - Labeling, you will be responsible for ensuring compliance with key labeling regulations and guidance, including CCDS, USPI, and packaging.You will have a strong working knowledge of labeling regulations and experience in label development, research,...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India Amazon Kuiper Services India Private Limited - Q38 Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Amazon Kuiper Services India Private Limited - Q38. As a key member of our Global Regulatory Affairs team, you will play a critical role in enabling and protecting our use of radio frequency spectrum and satellite orbits worldwide.Your primary responsibility will...
-
Regulatory Affairs Expert
3 days ago
Bengaluru, Karnataka, India Philips Full timeJob Title: Sr. Regulatory Affairs SpecialistYou will be an integral member of our Clinical Informatics Regulatory Affairs team, influencing and shaping the regulatory capabilities for future success of Philips.Your Key Responsibilities:Ensure safe and effective products/solutions are brought to market on time and sustained throughout their lifecycle via...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Parexel Full timeUnlock Your Potential as a Regulatory Affairs ConsultantAbout the Role:We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel. As a key member of our regulatory team, you will be responsible for providing expert guidance on regulatory matters related to drug products, including pre and post-approval life cycle...
-
Regulatory Affairs Specialist
6 days ago
Bengaluru, Karnataka, India Amazon Kuiper Services India Private Limited - Q38 Full timeJob DescriptionAmazon Kuiper Services India Private Limited - Q38 is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Global Regulatory Affairs team, you will play a critical role in enabling and protecting Kuiper's use of radio frequency spectrum and satellite orbits worldwide.About the RoleThe successful...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India Baxter Full timeTransforming Healthcare through Regulatory ExcellenceBaxter is a leading global innovator in medical products and therapies. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance and quality of our products.Your key responsibilities will include:Creating and reviewing regulatory documentation for product...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Parexel Full timeJob Description:Unlock Your Potential in Regulatory AffairsParexel is seeking a highly skilled Regulatory Affairs Consultant to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with regulatory requirements for biologic products in various markets.Key Responsibilities:Develop and implement regulatory...
-
Regulatory Affairs Specialist
3 days ago
Bengaluru, Karnataka, India Parexel Full timeAbout the RoleParexel is seeking a highly skilled Regulatory Affairs professional to join our team. As a Regulatory Affairs Consultant, you will be responsible for managing the pre- and post-approval life cycle of biologic products in various markets, including regulated (EU/US/Canada) and emerging markets.Key ResponsibilitiesDevelop and implement regulatory...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India ResMed Full timeThe Regulatory Affairs function at ResMed plays a crucial role in ensuring compliance with regulatory frameworks and delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in execution.Key Responsibilities:Support and maintain various internal and government databases relevant to ResMed's...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India ResMed Full timeJob SummaryThe Regulatory Affairs function at ResMed plays a critical role in ensuring compliance with regulatory requirements and delivering optimal regulatory strategies for product planning, active regulatory intelligence, and execution excellence. As a key member of the team, you will be responsible for providing support and guidance on regulatory...
