Final Reviewer & Certification Decision Maker
WFA Digital Insight
The remote job market has seen a significant surge in demand for professionals with expertise in regulatory compliance, particularly in the medical device sector. With the EU's MDR 2017/745 regulations coming into effect, companies like SGS are looking for skilled candidates to fill critical roles. As a Final Reviewer & Certification Decision Maker, you'll be at the forefront of ensuring compliance and making informed decisions. With demand for regulatory professionals expected to grow by over 20% in the next year, this role presents a unique opportunity for career advancement. Before applying, candidates should be aware of the complexities of medical device regulations and the importance of attention to detail in this field.
Job Description
About the Role
The Final Reviewer & Certification Decision Maker plays a pivotal role in SGS's Global Medical Device team, responsible for reviewing audit packs to verify compliance with MDD 93/42 EC or MDR (EU) 2017/745. This global role requires a deep understanding of medical device regulations and the ability to make informed decisions regarding certificate issuance. The successful candidate will be part of a highly successful team and will report to the Final Reviewer & Certification Decision Maker Medical Device Team Leader.The role entails a high level of responsibility, as the candidate will be accountable for ensuring that all audit documentation is compliant with medical device regulations and internal procedures. This includes verifying that audit packs have been thoroughly reviewed, and any major non-conformities or issues have been addressed and closed out.
What You Will Do
- Review audit packs to verify compliance with MDD 93/42 EC or MDR (EU) 2017/745
- Make informed decisions regarding certificate issuance based on audit pack reviews
- Verify that audit documentation is in compliance with medical device regulations and internal procedures
- Ensure that all major non-conformities or issues have been addressed and closed out
- Review final review documentation to ensure it has been completed satisfactorily
- Confirm that all actions raised by the Final Reviewer have been satisfactorily addressed and closed out
- Collaborate with auditors, product assessors, and other stakeholders to ensure seamless operations
- Participate in concessions and certificate suspension when relevant
- Stay up-to-date with changes in medical device regulations and internal procedures
- Contribute to meeting operations objectives and Key Performance Indicators
- Deliver high-quality certificates to customers while maintaining regulatory compliance
What We Are Looking For
- Strong understanding of medical device regulations, including MDD 93/42 EC and MDR (EU) 2017/745
- Experience in a similar role, preferably in the medical device industry
- Excellent analytical and decision-making skills
- Ability to work independently and as part of a global team
- Strong communication and interpersonal skills
- Proficiency in English, with additional languages being an asset
- Experience with audit packs and certification processes
- Knowledge of internal procedures and quality management systems
- Certification in a relevant field, such as ISO 13485
Nice to Have
- Experience with remote work and digital collaboration tools
- Familiarity with concessions and certificate suspension processes
- Knowledge of industry-specific software and systems
- Certification in a related field, such as regulatory affairs
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a global leader in the medical device industry
- Collaborative and dynamic work environment
- Professional development and growth opportunities
- Flexible working hours and remote work options
- Access to cutting-edge technology and tools
- Comprehensive health insurance and wellness programs
- Generous paid time off and holiday entitlement
How to Stand Out
- Ensure you have a strong understanding of medical device regulations, including MDD 93/42 EC and MDR (EU) 2017/745, to stand out as a candidate.
- Highlight your experience with audit packs and certification processes in your application and during interviews.
- Showcase your ability to work independently and as part of a global team, as this role requires collaboration with stakeholders across different time zones.
- Be prepared to discuss your decision-making process and how you handle complex regulatory issues.
- Consider obtaining certifications in relevant fields, such as ISO 13485, to demonstrate your expertise and commitment to the role.
- When negotiating salary, research the market rate for similar positions in the industry to ensure you're fairly compensated.
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