Staff Regulatory Specialist- Post Market Intelligence

Work Flexibility: Hybrid

What you will do-

- Perform adverse event assessment and regulatory reporting activities for medical devices in accordance with applicable global regulatory requirements.
- Review and evaluate product complaints and post-market information to determine reportability, regulatory timelines, and applicable reporting requirements.
- Prepare, submit, and maintain adverse event reports / Medical Device Reports (MDRs) and other regulatory submissions to applicable health authorities.
- Support post-market surveillance activities by analyzing complaint and adverse event data to identify emerging trends, potential safety signals, and reportable events.
- Collaborate with Quality, Regulatory Affairs, Medical Safety, Engineering, Clinical, and Complaint Management teams to obtain information required for timely and accurate regulatory reporting and ensure regulatory submissions are complete, accurate, consistent, and submitted within defined timelines.
- Support regulatory reporting activities across multiple global markets, as applicable, including US and Europe and maintain accurate documentation and records related to adverse event assessments, regulatory submissions, follow-ups, and correspondence with health authorities.
- Perform follow-up activities for adverse events, including gathering missing information and updating regulatory reports when required.
- Support regulatory and internal audits by providing appropriate documentation, records, and evidence related to post-market reporting activities.
- Identify opportunities to standardize, simplify, and automate PMI/AER processes while maintaining compliance with applicable regulations and procedures.
- Participate in process improvement, risk management, and continuous improvement initiatives within the Post Market Intelligence organization.
- Stay current with changes in global medical device regulations, reporting requirements, guidance documents, and internal procedures relevant to adverse event reporting.

What you will need:

Required Skills-

- Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, Regulatory Affairs, or a related field and relevant 3 years of experience in Adverse event reporting within the medical device, healthcare, pharmaceutical, or life sciences industry.
- Experience - 7 years -10 years
- Relevant experience in medical device, pharmaceutical, healthcare, or other regulated industry, preferably in Post Market Surveillance, Regulatory Affairs, Complaint Management, or Adverse Event Reporting.
- Working knowledge of global medical device regulatory requirements and adverse event reporting processes and understanding of post-market surveillance, vigilance, complaint handling, and medical device safety concepts.
- Experience in evaluating complaints and determining regulatory reportability and applicable reporting timelines.
- Ability to interpret and apply regulations, regulatory guidance, and internal procedures to individual cases; to manage multiple cases and priorities while meeting time-sensitive regulatory deadlines. And ability to work independently, make sound decisions within defined procedures, and escalate complex or potentially high-risk cases appropriately.
- Strong analytical and problem-solving skills with a high level of attention to detail and accuracy and written and verbal communication skills, with the ability to collaborate effectively with cross-functional and global teams.
- Proficiency in Microsoft Office applications, particularly Excel and PowerPoint.

Preferred Skills -

- Experience with Medical Device Reporting (MDR), vigilance reporting, or Adverse Event Reporting (AER); complaint management, regulatory reporting, or safety databases; regulatory intelligence and interpretation of changing regulatory requirements; process improvement methodologies such as Lean Six Sigma.
- Knowledge of regulations and reporting requirements across markets such as FDA/US, EU, Japan, China, Australia, and Canada.
- Familiarity with ISO 13485, ISO 14971, EU MDR, FDA regulations, and applicable post-market surveillance requirements.
- Knowledge of root cause analysis, risk management, and trend analysis.
- Exposure to automation and digital tools such as Power BI, Power Automate, Excel VBA, or similar technologies.
- Experience working in a global, cross-functional environment and supporting multiple geographies.
- Strong stakeholder-management skills and ability to effectively communicate with teams across different functions and regions.

Travel Percentage: 10%