Regulatory Manager responsible for developing global strategies for orthopedic implants at Acumed. Ensures compliance with regulatory applications and directs departmental projects.
About the role
- Senior Regulatory Affairs Specialist ensuring compliance with worldwide regulatory requirements at Argen. Responsible for developing regulatory strategies, submitting filings, and leading compliance activities.
Responsibilities
- Develop and implement global regulatory strategies for new product development, product modifications, and market expansion, supporting timely market access and business objectives.
- Prepare and submit regulatory submissions, including FDA 510(k)s, EU MDR Technical Documentation, UKCA submissions, and other global regulatory filings, ensuring accuracy, completeness, and adherence to applicable requirements.
- Lead and support compliance activities under EU MDR 2017/745 and UK MDR, including Technical Documentation, clinical evaluation oversight, PMS alignment, and coordination with Notified Bodies and regulatory entities.
- Provide regulatory oversight and review of Clinical Evaluation Reports (CERs) and related clinical documentation to ensure alignment with regulatory requirements, risk management, and intended use.
- Lead regulatory review and approval of labeling and IFU updates, ensuring compliance with EU MDR, UK MDR, FDA, and other applicable regulations.
- Manage and maintain global product registrations, device listings, licenses, and certificates, ensuring timely renewals, variations, and continued market access.
- Liaise with regulatory authorities and notified bodies to facilitate timely review and approval of regulatory submissions, and to address questions and requests for additional information.
- Manage and maintain product registrations, licenses, and certificates for domestic and international markets, ensuring timely renewals and updates.
- Provide guidance and support to cross-functional teams on regulatory requirements and standards, ensuring regulatory compliance throughout the product lifecycle.
- Conduct regulatory impact assessments and risk analysis to evaluate and mitigate potential regulatory risks and challenges.
- Develop and maintain regulatory affairs procedures and processes to ensure consistent compliance with regulatory requirements.
- Support regulatory inspections and audits, including preparation, coordination, and response to findings and observations.
- Collaborate with cross-functional teams to assess the impact of design changes, labeling updates, and manufacturing process changes on regulatory compliance.
- Train and mentor regulatory affairs team members, fostering their professional growth and development.
- Establish and maintain relationships with key stakeholders, including regulatory authorities, industry associations, and trade organizations.
- Develops and implements regulatory standards related to company metrics.
- Ensures regulatory initiatives are in place and functional in the facilities and provides training and education as necessary.
- Ensures timely submission of all reporting data to maintain compliance with all regulatory agencies.
- Creates and reinforces a culture of teamwork and actively resolves conflicts within the team.
- Ensures compliance with established policies and procedures.
- Inspires and motivates staff to ensure a very high level of performance.
Requirements
- Bachelor’s degree in technically relevant field (Engineering, microbiology, etc.) preferred
- 10 years’ experience in the medical device industry or equivalent combination of education, training, and experience.
- In-depth knowledge of global regulatory requirements and standards, such as FDA regulations, ISO 13485, MDSAP, EU MDR, UK MDR, and other relevant regulations.
- Strong experience in preparing and submitting regulatory submissions, and technical documentation.
- Familiarity with regulatory processes and interactions with regulatory authorities and notified bodies.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and communicate regulatory requirements and updates to stakeholders.
- Detail-oriented with excellent organizational skills and the ability to manage multiple projects and priorities.
- Energetic and motivated personality with a strong work ethic and excellent time management skills to complete tasks independently and autonomously.
- Fluent in written and verbal skills necessary to successfully perform the essential functions, duties, and responsibilities of the role.
- Deals with confidential information and/or issues exercising discretion and judgement.
- Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training.
- Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, EU MDR 2017/745, UK MDR, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.
Benefits
- Health Plans
- Dental Plans
- Vision Plan
- 401k with Employer Match
- Paid Time Off and Paid Holidays
- Employee Events
- Wellness Programs
- Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more!
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