Title: Senior Regulatory Affairs Specialist
The key function of Senior Regulatory Affairs Specialist is to lead regulatory strategies for the projects on site and for local continuous improvement initiatives. Develop and support regulatory submissions related to the company's products. An essential member of the Regulatory Affairs group and to demonstrate flexibility as priorities change. Sustain site Regulatory Affairs compliance, based on cGMP requirements as outlines in FDA 21CFR820, ISO 13485, MDR, CMDCAS, and other International Regulations.
- Key member of the New Product Introduction projects to ensure coordination with corporate commercialization strategies for Tier 1,2 and 3 ROW markets.
- Lead Product Support member of LCM projects to make sure continued device compliance to the market regulatory requirements.
- Review and approve product labelling materials for conformance with applicable regulations and standards.
- Engage in internal and external company regulatory/quality audits. Lead RA representative for site change management with contribution to RA metric reporting.
- Preserve currency and accuracy of CE Technical Files in accordance with device and process changes.
- Compose regulatory dossiers for submission to Health Authorities and maintain them along the process of product life cycle. Support proactive engagement with company and key stakeholders.
- Lead preparation of regulatory submissions to FDA 510(k), PMA supplements and dossiers for various other International Regulatory agencies.
- Keep track of global market regulatory changes, advise, and carry out changes to ensure compliance.
- Collaboration with general activities within the department which includes improving and implementing integrated regulatory business processes.
- Interpret new Medical Device Regulations and develop internal procedures to make sure compliance is upheld with all regulatory requirements.
- Certify Quality System compliance by adhering to established and evolving company QS requirements.
Education and Experience:
- Degree in an Engineering or Science discipline. Master's degree in an Engineering or Science discipline advantageous.
- Minimum of 7 year's experience in an RA role within an FDA and / or ISO 13485 regulated medical device environment.
- One-year of supervisor experience.
- Ability to adjust to changes in schedule and work well under pressure.
- Strong communication skills.
- Excellent attention to detail.
- Outstanding time management skills and proven ability to meet deadlines.
- Thrive in a fast-paced work environment and manage multiple tasks simultaneously.
- Pro-active and ability to work on own initiative while also being a team player.
- Skills to work on diverse project teams to provide Regulatory expertise and leadership.
- Proven track record in writing Regulatory medical device submissions.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.