Job Role Summary
This Regulatory Affairs position is a key role within our organization, requiring a skilled and experienced professional to manage regulatory submissions worldwide, maintain compliance to standards and regulations, and provide strategic regulatory insight.
About the Role:
* Spearhead regulatory activities and projects to enhance compliance and drive business growth.
* Develop and implement MDSAP strategies across the organization.
* Coordinate global registration activities for medical devices, ensuring timely and accurate submissions.
* Collaborate with the Commercial Team and Distributors to ensure country-specific registration requirements are met.
* Liaise with interdisciplinary teams to ensure quality management systems align with regulatory requirements.
* Support QA in audit preparation, internal and external audits, including notified body audits.
* Contribute to product development plans by providing strategic regulatory guidance.
* Manage Post Market Surveillance activities, including complaint logging, investigation coordination, and trend analysis.
* Maintain awareness of global regulatory trends and changes, advising colleagues on compliance and non-compliance.
* Evaluate manufacturing and labeling changes for regulatory impact and compliance.
* Collaborate with the team to prepare international regulatory filings, including 510(k) submissions.
Requirements:
* Bachelor's degree in Engineering or Science with minimum 3 years' experience in regulatory affairs, preferably in the medical device industry.
* Regulatory certifications in EU MDR and US FDA desirable.
* Proven understanding of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CFR 820, and supporting standards.
* Project management skills with ability to meet deadlines.
* Experience working directly with regulatory agencies.
Benefits:
* Competitive Salary, Bonus, Pension, Healthcare, and opportunities for career growth.
* Chance to develop expertise in regulatory affairs and contribute to innovative product development.